RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
FDA premarket approval P110013/S059 · decided 2016-07-22
Approval details
- PMA number
- P110013
- Supplement
- S059
- Supplement type
- Normal 180 Day Track No User Fee
- 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
- 2016-01-27
- Decision date
- 2016-07-22
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Approval to update the labeling for the Resolute Integrity Zotarolimus-Eluting Coronary Stent System Instructions for Use (IFU) for both the Rapid Exchange (RX) and Over-The-Wire (OTW) delivery systems to include the most current clinical follow-up data for the Global RESOLUTE Clinical Trial Program and the Resolute Integrity US (RI-US) Primary Enrollment Group (PEG) Post-Approval Study.
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