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ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER

FDA premarket approval P010020/S019 · decided 2010-12-16

Approval details

PMA number
P010020
Supplement
S019
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Trade name
ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER
Generic name
Implanted fecal incontinence device
Applicant
Boston Scientific Corp
Date received
2010-11-18
Decision date
2010-12-16
Days to decision
28 days
Decision code
APPR
Product code
MIP
Advisory committee
Gastroenterology, Urology
Expedited review
No
Location
Marlboro, MA
Statement
APPROVAL FOR A WARNING STATEMENT IN THE IFU PERTAINING TO THE APPROPRIATE CLEANING METHOD OF REUSABLE TOOLS USED IN THE ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER.

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