PMA N17755S048
- Device
- OSTEOBOND(TM) COPOLYMER BONE CEMENT
- Applicant
- Zimmer, Inc.
- PMA number
- N17755
- Supplement
- S048
- Product code
- LOD
- Decision date
- 1997-10-28
- Generic name
- BONE CEMENT
- Approval order statement
- Approval for a change in the gamma sterilization method of the Osteobond Copolymer Bone Cement powder component.
Current openFDA PMA Record#
- Device
- OSTEOBOND(TM) COPOLYMER BONE CEMENT
- Applicant
- Zimmer, Inc.
- PMA number
- N17755
- Supplement
- S048
- Product code
- LOD
- Generic name
- BONE CEMENT
- Decision date
- 1997-10-28
- Decision code
- APPR
- Date received
- 1996-08-30
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a change in the gamma sterilization method of the Osteobond Copolymer Bone Cement powder component.