AMS SPHINCTER 800 URINARY PROSTHESIS
FDA premarket approval P000053/S041 · decided 2012-08-21
Approval details
- PMA number
- P000053
- Supplement
- S041
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AMS SPHINCTER 800 URINARY PROSTHESIS
- Generic name
- Device, incontinence, mechanical/hydraulic
- Applicant
- Boston Scientific Corp
- Date received
- 2012-03-07
- Decision date
- 2012-08-21
- Days to decision
- 167 days
- Decision code
- APPR
- Product code
- EZY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlboro, MA
- Statement
- APPROVAL FOR REVISION OF THE AMOUNT OF RIFAMPIN AND MINOCYCLINE SPECIFIED IN THE INSTRUCTION FOR USE AND THE OPERATING ROOM MANUAL.
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