ENDURANT AND ENDURANT II STENT GRAFT SYSTEM
FDA premarket approval P100021/S038 · decided 2014-07-08
Approval details
- PMA number
- P100021
- Supplement
- S038
- Supplement type
- Special (Immediate Track)
- Trade name
- ENDURANT AND ENDURANT II STENT GRAFT SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2014-06-09
- Decision date
- 2014-07-08
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR INTRODUCING A LAMP MANDREL AS A MANUFACTURING TOOL FOR RADIOPAQUE CONTRALATERAL GATE MARKER INSPECTION OF ENDURANT AND ENDURANT II BIFURCATED STENT GRAFTS AND A COIL DISPENSER AS A VISUAL AID DURING THE PRE-KITTING PROCESS OF ENDURANT II STENT GRAFTS.
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