Bulkamid Urethral Bulking System
FDA premarket approval P170023 · decided 2020-01-28
Approval details
- PMA number
- P170023
- Trade name
- Bulkamid Urethral Bulking System
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Applicant
- Boston Scientific Corporation
- Date received
- 2017-07-31
- Decision date
- 2020-01-28
- Days to decision
- 911 days
- Decision code
- APPR
- Product code
- LNM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlborough, MA
- Statement
- Approval for the Bulkamid Urethral Bulking System. The device is indicated for urethral injection for the treatment of stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) in adult women who have SUI or stress predominant mixed incontinence.
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