Barrier, Absorbable, Adhesion
Basic Information
- Device Name
- Barrier, Absorbable, Adhesion
- Trade Name
- SEPRAFILM ADHESION BARRIER
- PMA Number
- P950034
- Supplement Number
- S022
- Device Class
- FDA Class 3
- Product Code
- MCN
- Generic Name
- Barrier, absorbable, adhesion
- Medical Specialty
- Unknown
- Advisory Committee
- General, Plastic Surgery
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- October 25, 2002
- Date Received
- September 24, 2002
- Supplement Type
- Real-Time Process
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR REVISED LABELING FOR SEPRAFILM ADHESION BARRIER TO REFLECT THE INTERIM FINDINGS OF THE STUDY APPROVED UNDER G980066, "A PROSPECTIVE, RANDOMIZED, MULTICENTER, CONTROLLED EVALUATION OF THE EFFICACY AND SAFETY OF SEPRAFILM BIORESORBABLE MEMBRANE IN THE REDUCTION OF THE INCIDENCE OF BOWEL OBSTRUCTION OF GENERAL SURGERY." THE DEVICE, WITH THE MODIFIED LABELING, WILL BE MARKETED UNDER THE TRADE NAME SEPRAFILM ADHESION BARRIER, AND IS INDICATED FOR USE IN PATIENTS UNDERGOING ABDOMINAL OR PELVIC LAPAROTOMY AS AN ADJUNCT INTENDED TO REDUCE THE INCIDENCE, EXTENT, AND SEVERITY OF POSTOPERATIVE ADHESIONS BETWEEN THE ABDOMINAL WALL AND THE UNDERLYING VISCERA SUCH AS OMENTUM, SMALL BOWEL, BLADDER AND STOMACH, AND BETWEEN THE UTERUS AND SURROUNDING STRUCTURES SUCH AS TUBES AND OVARIES, LARGE BOWEL, AND BLADDER.
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 |