AMS 800 ARTIFICIAL URINARY SPHINCTER
FDA premarket approval P000053/S026 · decided 2009-08-13
Approval details
- PMA number
- P000053
- Supplement
- S026
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AMS 800 ARTIFICIAL URINARY SPHINCTER
- Generic name
- Device, incontinence, mechanical/hydraulic
- Applicant
- Boston Scientific Corp
- Date received
- 2009-07-14
- Decision date
- 2009-08-13
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- EZY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlboro, MA
- Statement
- REPLACEMENT OF DIPPING EQUIPMENT USED IN THE MANUFACTURE OF THE DEVICES.
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