ACTICON ARTIFICAL BOWEL SPHINCTER (ABS)
FDA premarket approval P010020/S013 · decided 2009-04-08
Approval details
- PMA number
- P010020
- Supplement
- S013
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ACTICON ARTIFICAL BOWEL SPHINCTER (ABS)
- Generic name
- Implanted fecal incontinence device
- Applicant
- Boston Scientific Corp
- Date received
- 2009-03-09
- Decision date
- 2009-04-08
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MIP
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlboro, MA
- Statement
- USE OF AN ALTERNATE FLOW METER TO BE USED DURING THE TESTING OF THE DEVICES¿ CONTROL PUMP AND THE USE OF AN ALTERNATE DISINFECTANT CLEANER FOR SANITIZATION OF THE DEVICE TESTER.
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