PMA P010020S030
- Device
- AMS ACTICON NEOSPHINCTER- ARTIFICIAL BOWEL SPHINCTER (ABS)
- Applicant
- Boston Scientific Corp
- PMA number
- P010020
- Supplement
- S030
- Product code
- MIP
- Decision date
- 2015-04-08
- Generic name
- Implanted fecal incontinence device
- Approval order statement
- ACCEPTANCE OF A CHANGE TO IN-PROCESS MEASUREMENT EQUIPMENT.
Current openFDA PMA Record#
- Device
- AMS ACTICON NEOSPHINCTER- ARTIFICIAL BOWEL SPHINCTER (ABS)
- Applicant
- Boston Scientific Corp
- PMA number
- P010020
- Supplement
- S030
- Product code
- MIP
- Generic name
- Implanted fecal incontinence device
- Decision date
- 2015-04-08
- Decision code
- OK30
- Date received
- 2015-03-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ACCEPTANCE OF A CHANGE TO IN-PROCESS MEASUREMENT EQUIPMENT.