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 | NEUROCONTROL FREEHAND SYSTEM |
Generic Name | Stimulator, neuromuscular, implanted |
Regulation Number | 882.5860 |
Applicant | BIOCONTROL TECHNOLOGY, INC. 1945 EAST 97TH CLEVELAND, OH 44106-4720 |
PMA Number | P950035 |
Supplement Number | S007 |
Date Received | 03/14/2000 |
Decision Date | 06/23/2000 |
Product Code |
GZC |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE DISTRIBUTION OF AN IMPLANT TESTER ACCESSORY WHICH IS USED IN FINAL DEVICE TESTING AT THE COMPLETION OF SURGERY. |
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