BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS
FDA premarket approval P960053/S003 · decided 2002-12-31
Approval details
- PMA number
- P960053
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS
- Generic name
- Prosthesis, finger, constrained, metal/polymer
- Applicant
- Stryker Corporation
- Date received
- 2002-11-08
- Decision date
- 2002-12-31
- Days to decision
- 53 days
- Decision code
- APPR
- Product code
- KWG
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Selzach
- 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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