PMA P900030S010
- Device
- CONTIGEN BARD COLLAGEN IMPLANT
- Applicant
- Allergan, Inc.
- PMA number
- P900030
- Supplement
- S010
- Product code
- LNM
- Decision date
- 2008-01-11
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Approval order statement
- APPROVAL FOR UPDATED DIRECTIONS FOR USE IN ORDER TO STRENGTHEN INFORMATION ON ADVERSE EVENTS.
Current openFDA PMA Record#
- Device
- CONTIGEN BARD COLLAGEN IMPLANT
- Applicant
- Allergan, Inc.
- PMA number
- P900030
- Supplement
- S010
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2008-01-11
- Decision code
- APPR
- Date received
- 2007-12-18
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR UPDATED DIRECTIONS FOR USE IN ORDER TO STRENGTHEN INFORMATION ON ADVERSE EVENTS.