VALIANT THORACIC STENT GRAFT SYSTEM WITH CAPTIVIA DELIVERY SYSTEM
FDA premarket approval P100040/S017 · decided 2014-04-30
Approval details
- PMA number
- P100040
- Supplement
- S017
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VALIANT THORACIC STENT GRAFT SYSTEM WITH CAPTIVIA DELIVERY SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2014-02-07
- Decision date
- 2014-04-30
- Days to decision
- 82 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR THE ADDITION OF THE FREEFLO TAPARED STENT-GRAFTS TO THE LIST OF DEVICES INDICATED FOR TREATING THORACIC AORTIC DISSECTIONS,
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