ZIMMER(R) BONE CEMENT DOUGH-TYPE, ZIMMER(R) L.V.C.(R) LOW VIXCOSITY BONE CEMENT AND OSTEOBOND(TM) COPOLYMER BONE CEMENT
FDA premarket approval N17755/S045 · decided 1996-10-17
Approval details
- PMA number
- N17755
- Supplement
- S045
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ZIMMER(R) BONE CEMENT DOUGH-TYPE, ZIMMER(R) L.V.C.(R) LOW VIXCOSITY BONE CEMENT AND OSTEOBOND(TM) COPOLYMER BONE CEMENT
- Generic name
- BONE CEMENT
- Applicant
- Zimmer, Inc.
- Date received
- 1995-06-22
- Decision date
- 1996-10-17
- Days to decision
- 483 days
- Decision code
- APPR
- Product code
- LOD
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- CHANGE IN ETHYLENE OXIDE STERILIZATIN PROCESS USED IN THE STERILIZATION OF THE EXTERNAL SURFACE OF THE BONE CEMENT'S MONOMER AMPULES
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