PMA P900030S009
- Device
- CONTIGEN BARD COLLAGEN IMPLANT
- Applicant
- Allergan, Inc.
- PMA number
- P900030
- Supplement
- S009
- Product code
- LNM
- Decision date
- 2006-09-21
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Approval order statement
- APPROVAL FOR REVISED DIRECTIONS FOR USE (DFU) THAT INCLUDE INFORMATION FROM THE POST-APPROVAL STUDY ON COHORT B.
Current openFDA PMA Record#
- Device
- CONTIGEN BARD COLLAGEN IMPLANT
- Applicant
- Allergan, Inc.
- PMA number
- P900030
- Supplement
- S009
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2006-09-21
- Decision code
- APPR
- Date received
- 2005-06-13
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR REVISED DIRECTIONS FOR USE (DFU) THAT INCLUDE INFORMATION FROM THE POST-APPROVAL STUDY ON COHORT B.