PMA N18466S019
- Device
- CMW 1 RADIOPAQUE, CMW2 AND CMW3 BONE CEMENTS
- Applicant
- Depuy, Inc.
- PMA number
- N18466
- Supplement
- S019
- Product code
- LOD
- Decision date
- 1995-11-20
- Generic name
- BONE CEMENT
- Approval order statement
- APPROVAL FOR CMW 1 RADIOPAQUE, CMW2 AND CMW3 TO BE MARKETED UNDER WRIGHT MEDICAL AS:ORTHOSET 1, ORTHOSET 2, AND ORTHOSET 3 BONE CEMENT, RESPECTIVELY.
Current openFDA PMA Record
- Device
- CMW 1 RADIOPAQUE, CMW2 AND CMW3 BONE CEMENTS
- Applicant
- Depuy, Inc.
- PMA number
- N18466
- Supplement
- S019
- Product code
- LOD
- Generic name
- BONE CEMENT
- Decision date
- 1995-11-20
- Decision code
- APPR
- Date received
- 1995-09-20
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR CMW 1 RADIOPAQUE, CMW2 AND CMW3 TO BE MARKETED UNDER WRIGHT MEDICAL AS:ORTHOSET 1, ORTHOSET 2, AND ORTHOSET 3 BONE CEMENT, RESPECTIVELY.