- Device
- Bulkamid Urethral Bulking System
- Applicant
- Boston Scientific Corporation
- PMA number
- P170023
- Supplement
- S003
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2020-10-22
- Decision code
- APPR
- Date received
- 2020-08-13
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for changes in the primary packaging of Bulkamid Urethral Bulking System (Bulkamid Rotatable Sheath), upgrade to the corresponding process equipment, and replacement of the pouch sealing machine