PMA P010020S017
- Device
- ACTICON NEOSPHINTER
- Applicant
- Boston Scientific Corp
- PMA number
- P010020
- Supplement
- S017
- Product code
- MIP
- Decision date
- 2012-05-07
- Generic name
- Implanted fecal incontinence device
- Approval order statement
- APPROVAL FOR CHANGES IN THE MATERIAL FORMULATION AND SPECIFICATIONS OF THE SUTURE-TIE CONNECTORS.
Current openFDA PMA Record
- Device
- ACTICON NEOSPHINTER
- Applicant
- Boston Scientific Corp
- PMA number
- P010020
- Supplement
- S017
- Product code
- MIP
- Generic name
- Implanted fecal incontinence device
- Decision date
- 2012-05-07
- Decision code
- APPR
- Date received
- 2010-11-15
- Supplement type
- Normal 180 Day Track
- Approval order statement
- APPROVAL FOR CHANGES IN THE MATERIAL FORMULATION AND SPECIFICATIONS OF THE SUTURE-TIE CONNECTORS.