MEDTRONIC VASCULAR TALENT ABDOMINAL STENT GRAFT SYSTEM
FDA premarket approval P070027/S001 · decided 2008-07-15
Approval details
- PMA number
- P070027
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC VASCULAR TALENT ABDOMINAL STENT GRAFT SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2008-05-15
- Decision date
- 2008-07-15
- Days to decision
- 61 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR USE OF THE NEW XCELERANT HYDRO DELIVERY SYSTEM WITH THE TALENT ABDOMINAL STENT GRAFT.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.