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. |
|
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 | S003 |
Date Received | 12/02/1998 |
Decision Date | 01/19/1999 |
Product Code |
GZC |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a new manufacturing site located at NeuroControl Corporation, 8333 Rockside Road, Valley View, OH. |
|
|