FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Barrier, Absorbable, Adhesion
PMA: P880047
·
Supplement: S006
·
Decision May 5, 1999
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
- S006
- 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
- May 5, 1999
- Date Received
- August 28, 1998
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Approval for a manufacturing site located at Ethicon, Inc., Road 183 KM 8.3, Industrial Area Hato, San Lorenzo, Puerto Rico.
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 |