RESOLUTE MICROTRAC/RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
FDA premarket approval P110013 · decided 2012-02-17
Approval details
- PMA number
- P110013
- Trade name
- RESOLUTE MICROTRAC/RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
- Generic name
- Coronary drug-eluting stent
- Applicant
- Medtronic Vascular
- Date received
- 2011-04-01
- Decision date
- 2012-02-17
- Days to decision
- 322 days
- Decision code
- APWD
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR THE RESOLUTE MICROTRAC ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM AND RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS. THESE DEVICES ARE INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETERS IN PATIENTS, INCLUDING THOSE WITH DIABETES MELLITUS, WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DE NOVO LESIONS OF LENGTH 27 <= MM IN NATIVE CORONARY ARTERIES WITH REFERENCE VESSEL DIAMETERS OF 2.25 MM TO 4.2 MM.
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