| 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 | BIOELECTRON SPINALPAK II SPINE FUSION 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 | S015 |
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| Date Received | 09/30/2003 |
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| Decision Date | 01/12/2004 |
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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 | Normal 180 Day Track |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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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 A MODIFIED VERSION OF THE BIOELECTRON SPINALPAK FUSION STIMULATOR. THE MODIFICATIONS ARE: 1) THE CURRENT SPINALPAK IS POWERED BY 1 ALKALINE 9 VOLT BATTERY THAT MUST BE REPLACED DAILY. THE MODIFIED VERSION WILL BE POWERED BY 1 NIMN "AA" RECHARGEABLE CELL. THE CHARGER WILL BE INCLUDED. 2) THE HOUSING HAS BEEN MODIFIED TO ACCOMMODATE FOR A RECHARGEABLE BATTERY AND AN LCD DISPLAY. THE CURRENT SPINALPAK HAS AN LED DISPLAY. THE MODIFIED VERSION WILL HAVE A 6 MESSAGE LCD DISPLAY. 3) THE PCB CIRCUITRY HAS BEEN MODIFIED TO ACCOMMODATE THE LCD DISPLAY AND THE RECHARGEABLE BATTERY PACK. 4) THE ORIGINAL SOFTWARE WAS WRITTEN IN ASSEMBLY CODE. THE MODIFIED VERSION WAS REWRITTEN IN C. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BIOELECTRON SPINALPAK II SPINE FUSION STIMULATOR AND IS INDICATED AS AN ADJUNCT ELECTRICAL TREATMENT TO PRIMARY LUMBAR SPINAL FUSION SURGERY FOR ONE OR TWO LEVELS. |
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