PMA P010020S008
- Device
- ACTICON NEOSPHINCTER ARTIFICAL BOWEL SPINCTER
- Applicant
- Boston Scientific Corp
- PMA number
- P010020
- Supplement
- S008
- Product code
- MIP
- Decision date
- 2008-02-05
- Classification
- Gastroenterology, Urology
- Generic name
- Implanted fecal incontinence device
- Approval order statement
- CHANGE TO THE INCOMING INSPECTION CRITERIA FOR A MATERIAL USED IN THE MANUFACTURE OF THE DEVICE.
Current openFDA PMA Record#
- Device
- ACTICON NEOSPHINCTER ARTIFICAL BOWEL SPINCTER
- Applicant
- Boston Scientific Corp
- PMA number
- P010020
- Supplement
- S008
- Product code
- MIP
- Generic name
- Implanted fecal incontinence device
- Decision date
- 2008-02-05
- Decision code
- OK30
- Date received
- 2007-12-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE INCOMING INSPECTION CRITERIA FOR A MATERIAL USED IN THE MANUFACTURE OF THE DEVICE.