AMS SPHINCTER 800 URINARY CONTROL SYSTEM
FDA premarket approval P000053 · decided 2001-06-14
Approval details
- PMA number
- P000053
- Trade name
- AMS SPHINCTER 800 URINARY CONTROL SYSTEM
- Generic name
- Device, incontinence, mechanical/hydraulic
- Applicant
- Boston Scientific Corp
- Date received
- 2000-12-19
- Decision date
- 2001-06-14
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- EZY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlboro, MA
- Statement
- APPROVAL FOR THE AMS SPHINCTER 800(TM) URINARY PROSTHESIS. THE DEVICE IS USED TO TREAT URINARY INCONTINENCE DUE TO REDUCED OUTLET RESISTANCE (INTRINSIC SPHINCTER DEFICIENCY) FOLLOWING PROSTATE SURGERY.
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