FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Implanted Fecal Incontinence Device
PMA: P010020
·
Supplement: S030
·
Decision Apr 8, 2015
Classifications
1
FEI Numbers
3
Registration Numbers
3
Basic Information
- Device Name
- Implanted Fecal Incontinence Device
- Trade Name
- AMS ACTICON NEOSPHINCTER- ARTIFICIAL BOWEL SPHINCTER (ABS)
- PMA Number
- P010020
- Supplement Number
- S030
- Device Class
- FDA Class 3
- Product Code
- MIP
- Generic Name
- Implanted fecal incontinence device
- Medical Specialty
- Unknown
- Advisory Committee
- Gastroenterology, Urology
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- April 8, 2015
- Date Received
- March 9, 2015
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
ACCEPTANCE OF A CHANGE TO IN-PROCESS MEASUREMENT EQUIPMENT.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MIP | Implanted Fecal Incontinence Device | FDA class 3 | Unknown |