OSTEOBOND(TM) COPOLYMER BONE CEMENT
FDA premarket approval N17755/S047 · decided 1996-07-31
Approval details
- PMA number
- N17755
- Supplement
- S047
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- OSTEOBOND(TM) COPOLYMER BONE CEMENT
- Generic name
- BONE CEMENT
- Applicant
- Zimmer, Inc.
- Date received
- 1996-06-21
- Decision date
- 1996-07-31
- Days to decision
- 40 days
- Decision code
- APPR
- Product code
- LOD
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- APPROVAL FOR THE ADDITION OF TERMINOLOGY OF "HALF BATCH, SINGLE BATCH, DOUBLE BATCH, HALF PACK, SINGLE PACK, AND DOUBLE PACK" TO THE PACKAGE LABELS FOR OSTEOBOND COPOLYMER BONE CEMENT
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