TALENT ABDOMINAL STENT GRAFT SYSTEM
FDA premarket approval P070027/S019 · decided 2010-07-01
Approval details
- PMA number
- P070027
- Supplement
- S019
- Supplement type
- 30-Day Notice
- Trade name
- TALENT ABDOMINAL STENT GRAFT SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2010-06-04
- Decision date
- 2010-07-01
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- CHANGE TO INTRODUCE THE MICROVU MEASUREMENT SYSTEM FOR THE DIMENSIONAL MEASUREMENTS OF EXTRUDED TUBING.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.