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 | BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS |
Generic Name | Prosthesis, finger, constrained, metal/polymer |
Regulation Number | 888.3220 |
Applicant | STRYKER CORPORATION BOHNACKERWEG 1 SELZACH CH 25 |
PMA Number | P960053 |
Supplement Number | S003 |
Date Received | 11/08/2002 |
Decision Date | 12/31/2002 |
Product Code |
KWG |
Advisory Committee |
Orthopedic |
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 FACILITY LOCATED AT RMS CO., MINNEAPOLIS, MINNESOTA AND A NEW STERILIZATION FACILITY LOCATED AT MICRONET MEDICAL, INC., ST. PAUL, MINNESOTA. |
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