| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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| Device | ORTHOPAK BONE GROWTH STIMULATOR |
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| Generic Name | Stimulator, bone growth, non-invasive |
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| Regulation Number | 890.5870 |
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| Applicant | Ahp Eos Buyer, Inc.
1 Gatehall Dr.
Suite 303
Parsippany, NJ 07054 |
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| PMA Number | P850022 |
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| Supplement Number | S012 |
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| Date Received | 07/09/1999 |
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| Decision Date | 07/26/1999 |
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| Reclassified Date | 05/18/2026 |
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| Product Code |
LOF |
| Advisory Committee |
Orthopedic |
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| Supplement Type | Real-Time Process |
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| Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
Approval for addition of a 3x5-inch package insert (to be used as a daily patient reminder of the key elements of OrthoPak unit maintenance) into the case of every shipped OrthoPak(R) unit. Each card contains the following information: Bioelectron, Inc., 800-524-0677 Call this number for batteries, electrodes, questions or billing inquiries. 1) Change battery every morning. 2) Change electrodes every 3-7 days or when they will not stick to your skin. Make sure yoru skin is clean and dry before applying new electrodes. |
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