TALENT THORACIC STENT GRAFT SYSTEM
FDA premarket approval P070007/S038 · decided 2016-04-05
Approval details
- PMA number
- P070007
- Supplement
- S038
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- TALENT THORACIC STENT GRAFT SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2015-01-16
- Decision date
- 2016-04-05
- Days to decision
- 445 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Approval of the following changes to the post-approval study for the device: sponsor proposes to terminate its THRIVE Trial PAS due to the device no longer beingmanufactured or commercially available.
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