VALIANT THORACIC STENT GRAFT WITH CAPTIVIA DELIVERY SYSTEM
FDA premarket approval P100040/S012 · decided 2014-01-22
Approval details
- PMA number
- P100040
- Supplement
- S012
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VALIANT THORACIC STENT GRAFT WITH CAPTIVIA DELIVERY SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2013-07-29
- Decision date
- 2014-01-22
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR THE VALIANT THORACIC STENT GRAFT WITH CAPTIVIA DELIVERY SYSTEM (VALIANT CAPTIVIA). THIS DEVICE IS INDICATED FOR THE ENDOVASCULAR REPAIR OF ALL LESIONS OF THE DESCENDING THORACIC AORTA (DTA) IN PATIENTS HAVING THE APPROPRIATE ANATOMY INCLUDING: 1) ILIAC OR FEMORAL ARTERY ACCESS VESSEL MORPHOLOGY THAT IS COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES, DEVICES OR ACCESSORIES; NONANEURYSMAL AORTIC DIAMETER IN THE RANGE OF 18 MM TO 42 MM (FUSIFORM AND SACCULAR ANEURYSMS/PENETRATING ULCERS),
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