Resolute Integrity Zotarolimus-Eluting Coronary Stent System
FDA premarket approval P110013/S088 · decided 2018-12-14
Approval details
- PMA number
- P110013
- Supplement
- S088
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Resolute Integrity Zotarolimus-Eluting Coronary Stent System
- Generic name
- Coronary drug-eluting stent
- Applicant
- Medtronic Vascular
- Date received
- 2018-01-16
- Decision date
- 2018-12-14
- Days to decision
- 332 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Approval for the Resolute Integrity Zotarolimus-Eluting Coronary Stent System. The device is 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 <= 35 mm in native coronary arteries with reference vessel diameters of 2.25 mm to 4.2 mm. In addition, the Resolute Integrity Zotarolimus-Eluting Coronary Stent System is indicated for treating de novo chronic total occlusions.
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