PMA P110013S024

Device: RESOLUTE INTEGRITY RX ZOTAROLIMUS ELUTING CORONARY SYSTEM
Applicant: Medtronic Vascular
PMA number: P110013
Supplement: S024
Product code: NIQ
Decision date: 2014-02-05
Classification: Coronary Drug-eluting Stent
Generic name: Coronary drug-eluting stent
Approval order statement: APPROVAL FOR A MODIFICATION TO THE RESIDUAL SOLVENTS ANALYTICAL TEST METHOD USED FOR THE TESTING OF THE C10 AND C19 POLYMERS, WHICH ARE A COMPONENT OF THE STENT COATING.

Current openFDA PMA Record#

Device: RESOLUTE INTEGRITY RX ZOTAROLIMUS ELUTING CORONARY SYSTEM
Applicant: Medtronic Vascular
PMA number: P110013
Supplement: S024
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2014-02-05
Decision code: APPR
Date received: 2013-08-09
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A MODIFICATION TO THE RESIDUAL SOLVENTS ANALYTICAL TEST METHOD USED FOR THE TESTING OF THE C10 AND C19 POLYMERS, WHICH ARE A COMPONENT OF THE STENT COATING.