PMA P170023
- Device
- Bulkamid Urethral Bulking System
- Applicant
- Boston Scientific Corporation
- PMA number
- P170023
- Supplement
- S013
- Product code
- LNM
- Decision date
- 2026-07-01
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Approval order statement
- Manufacturing the Bulkamid Hydrogel in new cleanrooms at the existing manufacturing site.
Current openFDA PMA Record#
- Device
- Bulkamid Urethral Bulking System
- Applicant
- Boston Scientific Corporation
- PMA number
- P170023
- Supplement
- S024
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2026-07-01
- Decision code
- OK30
- Date received
- 2026-06-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing the Bulkamid Hydrogel in new cleanrooms at the existing manufacturing site.