PMA P010020S028
- Device
- AMS ACTION NEOSPHINCTER ARTIFICIAL BOWL SPHINCTER (ABS)
- Applicant
- Boston Scientific Corp
- PMA number
- P010020
- Supplement
- S028
- Product code
- MIP
- Decision date
- 2014-11-18
- Generic name
- Implanted fecal incontinence device
- Approval order statement
- IMPLEMENTATION OF AN ADDITIONAL TRAY SEALER.
Current openFDA PMA Record#
- Device
- AMS ACTION NEOSPHINCTER ARTIFICIAL BOWL SPHINCTER (ABS)
- Applicant
- Boston Scientific Corp
- PMA number
- P010020
- Supplement
- S028
- Product code
- MIP
- Generic name
- Implanted fecal incontinence device
- Decision date
- 2014-11-18
- Decision code
- OK30
- Date received
- 2014-10-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- IMPLEMENTATION OF AN ADDITIONAL TRAY SEALER.