ENDURANT II STENT GRAFT SYSTEM
FDA premarket approval P100021/S032 · decided 2014-09-03
Approval details
- PMA number
- P100021
- Supplement
- S032
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ENDURANT II STENT GRAFT SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2013-12-26
- Decision date
- 2014-09-03
- Days to decision
- 251 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC MEXICO EG, IN SONORA, MEXICO.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.