Bulkamid Urethral Bulking System
FDA premarket approval P170023/S007 · decided 2020-12-17
Approval details
- PMA number
- P170023
- Supplement
- S007
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Bulkamid Urethral Bulking System
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Applicant
- Boston Scientific Corporation
- Date received
- 2020-11-24
- Decision date
- 2020-12-17
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- LNM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlborough, MA
- Statement
- a change in the sterilization site of the Bulkamid Needle, a component of the Bulkamid Urethral Bulking System
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