PMA P010020S002
- Device
- AMS ACTICON NEOSPHINCTER
- Applicant
- Boston Scientific Corp
- PMA number
- P010020
- Supplement
- S002
- Product code
- MIP
- Decision date
- 2006-12-21
- Classification
- Gastroenterology, Urology
- Generic name
- Implanted fecal incontinence device
- Approval order statement
- APPROVAL FOR LABELING CHANGES.
Current openFDA PMA Record#
- Device
- AMS ACTICON NEOSPHINCTER
- Applicant
- Boston Scientific Corp
- PMA number
- P010020
- Supplement
- S002
- Product code
- MIP
- Generic name
- Implanted fecal incontinence device
- Decision date
- 2006-12-21
- Decision code
- APPR
- Date received
- 2006-06-30
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR LABELING CHANGES.