FLEX MOBILE BEARING KNEE
FDA premarket approval P060037/S012 · decided 2011-01-31
Approval details
- PMA number
- P060037
- Supplement
- S012
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FLEX MOBILE BEARING KNEE
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Applicant
- Zimmer, Inc.
- Date received
- 2010-04-06
- Decision date
- 2011-01-31
- Days to decision
- 300 days
- Decision code
- APPR
- Product code
- NJL
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT ZIMMER ORTHOPEDIC MFG LTD. (AOLM), IN SHANNON INDUSTRIAL ESTATE, IRELAND AND A STERILIZATION SITE LOCATED AT ISOTRON, WESTPORT, IRELAND.
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