FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Barrier, Absorbable, Adhesion
PMA: P880047
·
Supplement: S010
·
Decision Jul 3, 2006
Classifications
1
FEI Numbers
17
Registration Numbers
17
Basic Information
- Device Name
- Barrier, Absorbable, Adhesion
- Trade Name
- INTERCEED (TC7) ABSORBABLE ADHESION BARRIER
- PMA Number
- P880047
- Supplement Number
- S010
- 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
- July 3, 2006
- Date Received
- February 28, 2006
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR A CHANGE TO THE YARN USED IN THE DEVICE.
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 |