Bulkamid Urethral Bulking System
FDA premarket approval P170023/S005 · decided 2020-12-02
Approval details
- PMA number
- P170023
- Supplement
- S005
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Bulkamid Urethral Bulking System
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Applicant
- Boston Scientific Corporation
- Date received
- 2020-09-04
- Decision date
- 2020-12-02
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- LNM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlborough, MA
- Statement
- Approval for minor changes to the Bulkamid Needle, including a change in the manufacturer for the Bulkamid Needle, which includes minor changes to the needle hubs outershape, the raw materials used for the needle hub and sterile barrier system (pouch), and the dimensions of the needle pouch.
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