PMA P010020S009
- Device
- ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER
- Applicant
- Boston Scientific Corp
- PMA number
- P010020
- Supplement
- S009
- Product code
- MIP
- Decision date
- 2008-05-30
- Classification
- Gastroenterology, Urology
- Generic name
- Implanted fecal incontinence device
- Approval order statement
- CONVERSION OF A PART OF THE PRODUCTION SYSTEM FROM A MANUAL TO A SOFTWARE AUTOMATED OPERATION.
Current openFDA PMA Record#
- Device
- ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER
- Applicant
- Boston Scientific Corp
- PMA number
- P010020
- Supplement
- S009
- Product code
- MIP
- Generic name
- Implanted fecal incontinence device
- Decision date
- 2008-05-30
- Decision code
- OK30
- Date received
- 2008-04-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CONVERSION OF A PART OF THE PRODUCTION SYSTEM FROM A MANUAL TO A SOFTWARE AUTOMATED OPERATION.