ENDURANT STENT GRAFT SYSTEM
FDA premarket approval P100021/S028 · decided 2013-09-12
Approval details
- PMA number
- P100021
- Supplement
- S028
- 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
- 2013-08-14
- Decision date
- 2013-09-12
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- ALTERNATE SECOND TIER-SUPPLIER OF POLYESTER YARN AND ABILITY TO USE THE MATERIAL FROM ALL POLYESTER GRAFT MATERIAL SUPPLIERS FOR ANY OF THE STENT-GRAFT ONFIGURATIONS
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.