FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Barrier, Absorbable, Adhesion
PMA: P050011
·
Supplement: S005
·
Decision Oct 29, 2013
Classifications
1
FEI Numbers
17
Registration Numbers
17
Basic Information
- Device Name
- Barrier, Absorbable, Adhesion
- Trade Name
- ADEPT ADHESION REDUCTION SOLUTION (4% ICODEXTRIN)
- PMA Number
- P050011
- Supplement Number
- S005
- Device Class
- FDA Class 3
- Product Code
- MCN
- Generic Name
- Barrier, absorbable, adhesion
- Medical Specialty
- Unknown
- Advisory Committee
- Obstetrics/Gynecology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- October 29, 2013
- Date Received
- August 2, 2013
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR A NEW POLYVINYLCHLORIDE STORAGE BAG FOR THE ADEPT ADHESION REDUCTION SOLUTION.
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 |
|---|---|---|---|
| MCN | Barrier, Absorbable, Adhesion | FDA class 3 | Unknown |