OSTEOBOND(TM) COPOLYMER BONE CEMENT
FDA premarket approval N17755/S048 · decided 1997-10-28
Approval details
- PMA number
- N17755
- Supplement
- S048
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- OSTEOBOND(TM) COPOLYMER BONE CEMENT
- Generic name
- BONE CEMENT
- Applicant
- Zimmer, Inc.
- Date received
- 1996-08-30
- Decision date
- 1997-10-28
- Days to decision
- 424 days
- Decision code
- APPR
- Product code
- LOD
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- Approval for a change in the gamma sterilization method of the Osteobond Copolymer Bone Cement powder component.
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