PMA P110013

Device: Resolute Integrity
Applicant: Medtronic Vascular
PMA number: P110013
Supplement: S117
Product code: NIQ
Decision date: 2022-09-29
Generic name: Coronary drug-eluting stent
Approval order statement: Approval for updated labeling for the the Resolute Onyx Zotarolimus-Eluting Coronary Stent System electronic Instructions for Use (eIFU) to reflect the long-term data from The RESOLUTE ONYX CTO Post-Approval Study.

Current openFDA PMA Record#

Device: Resolute Integrity
Applicant: Medtronic Vascular
PMA number: P110013
Supplement: S117
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2022-09-29
Decision code: APPR
Date received: 2022-04-07
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - PAS
Approval order statement: Approval for updated labeling for the the Resolute Onyx Zotarolimus-Eluting Coronary Stent System electronic Instructions for Use (eIFU) to reflect the long-term data from The RESOLUTE ONYX CTO Post-Approval Study.