AMS 800 Artificial Urinary Sphincter (AUS) with and without lnhibiZone
FDA premarket approval P000053/S137 · decided 2025-06-03
Approval details
- PMA number
- P000053
- Supplement
- S137
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- AMS 800 Artificial Urinary Sphincter (AUS) with and without lnhibiZone
- Generic name
- Device, incontinence, mechanical/hydraulic
- Applicant
- Boston Scientific Corp
- Date received
- 2025-03-07
- Decision date
- 2025-06-03
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- EZY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlboro, MA
- Statement
- approval for changes to the AMS 800 product packaging artwork, product labels, eLabeling Access Statement Insert, Physician Instructions for Use, Magnetic Resonance Imaging (MRI) Safety Information to support the MR Conditional labeling, and Patient Guide
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