PMA P010020S015
- Device
- ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER
- Applicant
- Boston Scientific Corp
- PMA number
- P010020
- Supplement
- S015
- Product code
- MIP
- Decision date
- 2010-04-23
- Generic name
- Implanted fecal incontinence device
- Approval order statement
- MODIFICATION OF A PARAMETER IN A RECEIVING INSPECTION TEST FOR SILICONE USED IN THE COATING PROCESS.
Current openFDA PMA Record#
- Device
- ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER
- Applicant
- Boston Scientific Corp
- PMA number
- P010020
- Supplement
- S015
- Product code
- MIP
- Generic name
- Implanted fecal incontinence device
- Decision date
- 2010-04-23
- Decision code
- OK30
- Date received
- 2010-03-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MODIFICATION OF A PARAMETER IN A RECEIVING INSPECTION TEST FOR SILICONE USED IN THE COATING PROCESS.