System, Endovascular Graft, Aortic Aneurysm Treatment
Basic Information
- Device Name
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Trade Name
- OVATION AND OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM
- PMA Number
- P120006
- Supplement Number
- S009
- Device Class
- FDA Class 3
- Product Code
- MIH
- Generic Name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- April 23, 2014
- Date Received
- November 12, 2013
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR A CHANGE TO THE INDICATION FOR USE FOR THE OVATION AND OVATION PRIME ABDOMINAL STENT GRAFT SYSTEMS BY CLARIFYING THAT PERCUTANEOUS ACCESS AND FEMORAL CUTDOWN ARE APPROPRIATE VASCULAR ACCESS TECHNIQUES. THE DEVICE, THE TRIVASCULAR OVATION AND OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM, IS INDICATED FOR TREATMENT OF PATIENTS WITH ABDOMINAL AORTIC ANEURYSMS HAVING THE VASCULAR MORPHOLOGY SUITABLE FOR ENDOVASCULAR REPAIR, INCLUDING:1) ADEQUATE ILIAC/FEMORAL ACCESS COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES (FEMORAL CUTDOWN OR PERCUTANEOUS), DEVICES, AND/OR ACCESSORIES; 2) PROXIMAL AORTIC LANDING ZONE:A) WITH AN INNER WALL DIAMETER OF NO LESS THAN 16 MM AND NO GREATER THAN 30 MM AT 13 MM BELOW THE INFERIOR RENAL ARTERY; AND B) WITH AN AORTIC ANGLE OF =< 60 DEGREES IF PROXIMAL NECK IS => 10 MM AND =<45 DEGREES IF PROXIMAL NECK IS <10 MM; AND 3) DISTAL ILIAC LANDING ZONE: A) WITH A LENGTH OF AT LEAST 10 MM; ANDB) WITH AN INNER WALL DIAMETER OF NO LESS THAN 8 MM AND NO GREATER THAN 20 MM.
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 |
|---|---|---|---|
| MIH | System, Endovascular Graft, Aortic Aneurysm Treatment | FDA class 3 | Unknown |