PMA P170023S015
- Device
- Bulkamid Urethral Bulking System
- Applicant
- Boston Scientific Corporation
- PMA number
- P170023
- Supplement
- S015
- Product code
- LNM
- Decision date
- 2023-07-12
- Classification
- Gastroenterology, Urology
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Approval order statement
- Approval for an additional Bulkamid Urethral Bulking System packaging configuration.
Current openFDA PMA Record#
- Device
- Bulkamid Urethral Bulking System
- Applicant
- Boston Scientific Corporation
- PMA number
- P170023
- Supplement
- S015
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2023-07-12
- Decision code
- APPR
- Date received
- 2023-04-17
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for an additional Bulkamid Urethral Bulking System packaging configuration.