Valiant Thoracic Stent Graft with the Captivia Delivery System
FDA premarket approval P100040/S037 · decided 2018-10-05
Approval details
- PMA number
- P100040
- Supplement
- S037
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Valiant Thoracic Stent Graft with the Captivia Delivery System
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2018-09-24
- Decision date
- 2018-10-05
- Days to decision
- 11 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Implement a new labeling system at the Galway facility.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.