PMA P170023S023
- Device
- Bulkamid Urethral Bulking System
- Applicant
- Boston Scientific Corporation
- PMA number
- P170023
- Supplement
- S023
- Product code
- LNM
- Decision date
- 2026-01-02
- Classification
- Gastroenterology, Urology
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Approval order statement
- removal of cytotoxicity testing from batch release testing.
Current openFDA PMA Record#
- Device
- Bulkamid Urethral Bulking System
- Applicant
- Boston Scientific Corporation
- PMA number
- P170023
- Supplement
- S023
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2026-01-02
- Decision code
- OK30
- Date received
- 2025-12-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- removal of cytotoxicity testing from batch release testing.