- Device
- ZIMMER(R) BONE CEMENT DOUGH-TYPE, ZIMMER(R) L.V.C.(R) LOW VIXCOSITY BONE CEMENT AND OSTEOBOND(TM) COPOLYMER BONE CEMENT
- Applicant
- Zimmer, Inc.
- PMA number
- N17755
- Supplement
- S045
- Product code
- LOD
- Generic name
- BONE CEMENT
- Decision date
- 1996-10-17
- Decision code
- APPR
- Date received
- 1995-06-22
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN ETHYLENE OXIDE STERILIZATIN PROCESS USED IN THE STERILIZATION OF THE EXTERNAL SURFACE OF THE BONE CEMENT'S MONOMER AMPULES