PMA N17755S046

Device: OSTEOBOND(TM) COPOLYMER BONE CEMENT
Applicant: Zimmer, Inc.
PMA number: N17755
Supplement: S046
Product code: LOD
Decision date: 1995-11-20
Generic name: BONE CEMENT
Approval order 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."

Current openFDA PMA Record#

Device: OSTEOBOND(TM) COPOLYMER BONE CEMENT
Applicant: Zimmer, Inc.
PMA number: N17755
Supplement: S046
Product code: LOD
Generic name: BONE CEMENT
Decision date: 1995-11-20
Decision code: APPR
Date received: 1995-10-11
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order 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."