OSTEOBOND(TM) COPOLYMER BONE CEMENT
FDA premarket approval N17755/S046 · decided 1995-11-20
Approval details
- PMA number
- N17755
- Supplement
- S046
- Supplement type
- Special (Immediate Track)
- 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
- 1995-10-11
- Decision date
- 1995-11-20
- 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 TO THE LABELING OF THE FOLLOWING WARNING STATEMENT: "DO NOT CENTRIGUGE OSTEOBOND COPOLYMER BONE CEMENT. ALTHOUGH CENTRIFUGATION HAS BEEN SHOWN IN SOME CASES TO IMPROVE THE PHYSICAL STRENGTH OF THE CURED CEMENT BY REMOVAL OF ENTRAPPED AIR AND OTHER GASES, A UNIFORM DISPERSION OF THE RADIOPACIFIER CANNOT BE ASSURED. THEREFORE, THE USE OF CENTRIGUGATION IS NOT ADVISABLE."
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