PMA P010020S032
- Device
- AMS ACTICON NEOSPHINCTER- ARTIFICIAL BOWL SPHINCTER (ABS)
- Applicant
- Boston Scientific Corp
- PMA number
- P010020
- Supplement
- S032
- Product code
- MIP
- Decision date
- 2015-05-06
- Generic name
- Implanted fecal incontinence device
- Approval order statement
- ADDITION OF THREE (3) DUPLICATE OVENS AS BACK-UP EQUIPMENT.
Current openFDA PMA Record
- Device
- AMS ACTICON NEOSPHINCTER- ARTIFICIAL BOWL SPHINCTER (ABS)
- Applicant
- Boston Scientific Corp
- PMA number
- P010020
- Supplement
- S032
- Product code
- MIP
- Generic name
- Implanted fecal incontinence device
- Decision date
- 2015-05-06
- Decision code
- OK30
- Date received
- 2015-04-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF THREE (3) DUPLICATE OVENS AS BACK-UP EQUIPMENT.