TALENT ABDOMINAL STENT GRAFT SYSTEM
FDA premarket approval P070027/S039 · decided 2014-07-16
Approval details
- PMA number
- P070027
- Supplement
- S039
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- TALENT ABDOMINAL STENT GRAFT SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2014-02-24
- Decision date
- 2014-07-16
- Days to decision
- 142 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.