ENDURANT STENT GRAFT SYSTEM
FDA premarket approval P100021/S030 · decided 2013-12-12
Approval details
- PMA number
- P100021
- Supplement
- S030
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ENDURANT STENT GRAFT SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2013-11-15
- Decision date
- 2013-12-12
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- CONSOLIDATE AND TRANSFER EXTRUSION ACTIVITIES TO THE SANTA ROSA, CA 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.