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Orbasone Detention by FDA

Posted by John on 7/28/00 at 12:42 (024170)

Dear Dr. Zuckerman:

I just read the product alert issued by the FDA on 6/29/00 calling for automatic detention of all Orbasone devices. I have inserted it here, FYI. Does this affect your ability to treat PF with your device or are you still allowed to use it?

IA#89-08, -----8/11/92 REVISED ATTACHMENT 6/29/00

TYPE OF ALERT: Automatic Detention

PRODUCT : Class III medical devices for which there are no approved PMA's or Investigational Device Exemptions (IDE), and all other devices that have not been determined substantially equivalent or for which a 510(k) has not been filed.

PRODUCT CODE: Multiple

HARMONIZED CODE : N/A

PROBLEM : Devices are being distributed without a 510(k) or approved PMA and are not the subject of an IDE.

COUNTRY : See Attachment

MANUFACTURER or SHIPPER : See Attachment

MANUFACTURER SHIPPER I.D.#: N/A

IMPORTER'S I.D.# : N/A

CHARGE : For Class III device: 'The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1) [Adulteration, Section 501(f)(1)(B)].'

For other devices: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a post 1976 device for which a Section 510(k) application has not been determined substantially equivalent or a 510(k) has not been filed [Misbranding, Section 502(o)]

RECOMMENDING OFFICE : CDRH, Office of Compliance and Surveillance Division of Compliance Operations Regulatory Guidance Branch HFZ-323

REASON FOR ALERT : Devices listed in the Attachment lack either a filed 510(k) or approved PMA (Pre Market Approval) for commercial distribution.

INSTRUCTIONS: Automatically detain all devices, as designated, from the manufacturers listed in the Attachment.

FOI : Purging between ^ ^ is required

KEYWORDS : 510(k), PMA, IDE, Medical devices, devices, Class III devices, Pre Market Approval Attachment to Import Alert #89-08 Revised 6/29/00

The following devices and firms are under automatic detention:

Manufacturer Device(s) / Date Added Class
.
Minimally Invasive Products, GmbH Orbasone> TM, aka Kreuzlingen, Switzerland
posted to the eswt board . . . keyword: Orbasone


Re: Orbasone Detention by FDA

Dr. Zuckerman on 7/28/00 at 16:15 (024183)

Thanks for the information. I am treating patients. No one has contacted my office about this at this time.
posted to the eswt board . . . keyword:

Re: Orbasone Detention by FDA

john h on 7/28/00 at 18:41 (024198)

what rotten luck!!!!! i am still on your schedule dr z. hope you do not hear from anyone soon.
posted to the eswt board . . . keyword:

Re: Orbasone Detention by FDA

Dr. Zuckerman on 7/29/00 at 16:31 (024246)

I am sitting here thinking about how to make sure that ESWT doesn't leave the Philadelphia-New Jersey at any time in the future. Would you consider bring an Ossatron to the South Jersey area . There is a Health South in my area ( fifteen miles). I do remember your gentleman's bet with me about removal of the orbasone . Will you take
a credit card. Can i use you as a reference should I contact Healthronics ???
posted to the eswt board . . . keyword:

Re: Orbasone Detention by FDA

john h on 7/29/00 at 18:57 (024254)

i understand John w's position on the orbasone but as one who has suffered for some years from PF i am very disappointed that i may not get treatment with EWST as planned next month. red tape once again leaves the patient between a rock and a hard place.
posted to the eswt board . . . keyword:

Re: Orbasone Detention by FDA

Dr. Zuckerman on 7/29/00 at 20:38 (024260)

I will be performing ESWT next month John. Can't promise you what machine I will be using but The war on Plantar fasciitis will not stop or slow down in my office!!!!!!!!!!!!!!!!!!!
posted to the eswt board . . . keyword:

Re: Orbasone Detention by FDA

johnw on 7/30/00 at 15:11 (024295)

I did not make the alert post. This detention was news to me. Dr. Z, now that I am 'between jobs' I'll take credit cards or small coins. Based on what I know about the fda, you will probably have your machine until it dies of old age.
posted to the eswt board . . . keyword:

Re: Orbasone Detention by FDA

johnw on 7/30/00 at 15:27 (024296)

Dr Z., call me sometime 770-926-9618
posted to the eswt board . . . keyword:

Re: Orbasone Detention by FDA

Dr. Zuckerman on 7/30/00 at 16:39 (024305)

I know that you didn't make this alert . When I thanked you I really did thank you. With my luck the obasone will die due to lack of parts,
The thing is going to need a new generator somewhere between one - three million pulses. The unwritten warranty is good for one million.
So it has about three hundred patients left in it, and that if somethng else doesn't go wrong . They need alot of maintance.

posted to the eswt board . . . keyword:

Re: Orbasone Detention by FDA

Dr. Zuckerman on 7/28/00 at 16:15 (024183)

Thanks for the information. I am treating patients. No one has contacted my office about this at this time.
posted to the eswt board . . . keyword:

Re: Orbasone Detention by FDA

john h on 7/28/00 at 18:41 (024198)

what rotten luck!!!!! i am still on your schedule dr z. hope you do not hear from anyone soon.
posted to the eswt board . . . keyword:

Re: Orbasone Detention by FDA

Dr. Zuckerman on 7/29/00 at 16:31 (024246)

I am sitting here thinking about how to make sure that ESWT doesn't leave the Philadelphia-New Jersey at any time in the future. Would you consider bring an Ossatron to the South Jersey area . There is a Health South in my area ( fifteen miles). I do remember your gentleman's bet with me about removal of the orbasone . Will you take
a credit card. Can i use you as a reference should I contact Healthronics ???
posted to the eswt board . . . keyword:

Re: Orbasone Detention by FDA

john h on 7/29/00 at 18:57 (024254)

i understand John w's position on the orbasone but as one who has suffered for some years from PF i am very disappointed that i may not get treatment with EWST as planned next month. red tape once again leaves the patient between a rock and a hard place.
posted to the eswt board . . . keyword:

Re: Orbasone Detention by FDA

Dr. Zuckerman on 7/29/00 at 20:38 (024260)

I will be performing ESWT next month John. Can't promise you what machine I will be using but The war on Plantar fasciitis will not stop or slow down in my office!!!!!!!!!!!!!!!!!!!
posted to the eswt board . . . keyword:

Re: Orbasone Detention by FDA

johnw on 7/30/00 at 15:11 (024295)

I did not make the alert post. This detention was news to me. Dr. Z, now that I am 'between jobs' I'll take credit cards or small coins. Based on what I know about the fda, you will probably have your machine until it dies of old age.
posted to the eswt board . . . keyword:

Re: Orbasone Detention by FDA

johnw on 7/30/00 at 15:27 (024296)

Dr Z., call me sometime 770-926-9618
posted to the eswt board . . . keyword:

Re: Orbasone Detention by FDA

Dr. Zuckerman on 7/30/00 at 16:39 (024305)

I know that you didn't make this alert . When I thanked you I really did thank you. With my luck the obasone will die due to lack of parts,
The thing is going to need a new generator somewhere between one - three million pulses. The unwritten warranty is good for one million.
So it has about three hundred patients left in it, and that if somethng else doesn't go wrong . They need alot of maintance.

posted to the eswt board . . . keyword: