AMS 800 Urinary Control System with and without InhibiZone
FDA premarket approval P000053/S092 · decided 2018-09-20
Approval details
- PMA number
- P000053
- Supplement
- S092
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AMS 800 Urinary Control System with and without InhibiZone
- Generic name
- Device, incontinence, mechanical/hydraulic
- Applicant
- Boston Scientific Corp
- Date received
- 2018-08-27
- Decision date
- 2018-09-20
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- EZY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlboro, MA
- Statement
- Relocation of and changes to the milling and molding process of the silicone balloon adapter component.
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