SPHINCTER 800 URINARY CONTROL SYSTEM
FDA premarket approval P000053/S005 · decided 2006-10-13
Approval details
- PMA number
- P000053
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SPHINCTER 800 URINARY CONTROL SYSTEM
- Generic name
- Device, incontinence, mechanical/hydraulic
- Applicant
- Boston Scientific Corp
- Date received
- 2005-01-04
- Decision date
- 2006-10-13
- Days to decision
- 647 days
- Decision code
- APPR
- Product code
- EZY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlboro, MA
- Statement
- APPROVAL FOR THE ADDITION OF INHIBIZONE TREATMENT TO COMPONENTS OF THE SPHINCTER 800 URINARY CONTROL SYSTEM, SPECIFICALLY THE CUFFS, PUMPS, AND KINK RESISTANT TUBING.
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