FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Barrier, Absorbable, Adhesion
PMA: P880047
·
Supplement: S011
·
Decision Nov 21, 2006
Classifications
1
FEI Numbers
17
Registration Numbers
17
Basic Information
- Device Name
- Barrier, Absorbable, Adhesion
- Trade Name
- INTERCEED ABSORBABLE ADHESION BARRIER
- PMA Number
- P880047
- Supplement Number
- S011
- Device Class
- FDA Class 3
- Product Code
- MCN
- Generic Name
- Barrier, absorbable, adhesion
- Medical Specialty
- Unknown
- Advisory Committee
- Obstetrics/Gynecology
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- November 21, 2006
- Date Received
- October 25, 2006
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
CHANGE IN THE PACKAGING MATERIAL.
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 |