Bulkamid Urethral Bulking System
FDA premarket approval P170023/S003 · decided 2020-10-22
Approval details
- PMA number
- P170023
- Supplement
- S003
- 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
- 2020-08-13
- Decision date
- 2020-10-22
- Days to decision
- 70 days
- Decision code
- APPR
- Product code
- LNM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlborough, MA
- 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
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