PMA P010020S006
- Device
- ACTICON NEOSPHINCTER ARTIFICAL BOWEL SPHINCTER
- Applicant
- Boston Scientific Corp
- PMA number
- P010020
- Supplement
- S006
- Product code
- MIP
- Decision date
- 2008-04-16
- Classification
- Gastroenterology, Urology
- Generic name
- Implanted fecal incontinence device
- Approval order statement
- APPROVAL FOR A CHANGE IN THE RELEASE AGENT USED IN THE DISPERSION PROCESS.
Current openFDA PMA Record#
- Device
- ACTICON NEOSPHINCTER ARTIFICAL BOWEL SPHINCTER
- Applicant
- Boston Scientific Corp
- PMA number
- P010020
- Supplement
- S006
- Product code
- MIP
- Generic name
- Implanted fecal incontinence device
- Decision date
- 2008-04-16
- Decision code
- APPR
- Date received
- 2007-07-02
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A CHANGE IN THE RELEASE AGENT USED IN THE DISPERSION PROCESS.