OSTEOBOND(TM) COPOLYMER BONE CEMENT
FDA premarket approval N17755/S044 · decided 1995-08-11
Approval details
- PMA number
- N17755
- Supplement
- S044
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- OSTEOBOND(TM) COPOLYMER BONE CEMENT
- Generic name
- BONE CEMENT
- Applicant
- Zimmer, Inc.
- Date received
- 1994-08-01
- Decision date
- 1995-08-11
- Days to decision
- 375 days
- Decision code
- APPR
- Product code
- LOD
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- CHANGES IN THE BONE CEMENT COMPOSITION TRADE NAME:OSTEOBOND COPOLYMER BONE CEMENT
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