FDA PMA
FDA Class 3
Approved (Withdrawn)
🇺🇸 United States
Barrier, Adhesion, Cardiovascular
PMA: P070005
·
Decision Mar 6, 2009
Classifications
1
FEI Numbers
1
Registration Numbers
1
Basic Information
- Device Name
- Barrier, Adhesion, Cardiovascular
- Trade Name
- REPEL-CV BIORESORBABLE ADHESION BARRIER
- PMA Number
- P070005
- Device Class
- FDA Class 3
- Product Code
- OBD
- Generic Name
- Barrier, adhesion, cardiovascular
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved (Withdrawn)
- Decision Code
- APWD
- Decision Date
- March 6, 2009
- Date Received
- January 30, 2007
- Expedited Review
- N
- Docket Number
- 09M-0135
Advisory Committee Statement
APPROVAL FOR THE REPEL-CV BIORESORBABLE ADHESION BARRIER. THE DEVICE IS INDICATED FOR REDUCING THE SEVERITY OF POST-OPERATIVE CARDIAC ADHESIONS IN PEDIATRIC PATIENTS WHO ARE LIKELY TO REQUIRE REOPERATION VIA STERNOTOMY.
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 |
|---|---|---|---|
| OBD | Barrier, Adhesion, Cardiovascular | FDA class 3 | Unknown |