PMA N17755S047

Device: OSTEOBOND(TM) COPOLYMER BONE CEMENT
Applicant: Zimmer, Inc.
PMA number: N17755
Supplement: S047
Product code: LOD
Decision date: 1996-07-31
Generic name: BONE CEMENT
Approval order 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

Current openFDA PMA Record#

Device: OSTEOBOND(TM) COPOLYMER BONE CEMENT
Applicant: Zimmer, Inc.
PMA number: N17755
Supplement: S047
Product code: LOD
Generic name: BONE CEMENT
Decision date: 1996-07-31
Decision code: APPR
Date received: 1996-06-21
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order 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