PMA P110013S031

Device: RESOLUTE INTEGRITY RX ZOTAROLIMUS-ELUTING CORNARY STENT SYSTEM; RESOLUTE INTEGRITY OTW ZOTAROLINUS ELUTING STENT SYSTEM
Applicant: Medtronic Vascular
PMA number: P110013
Supplement: S031
Product code: NIQ
Decision date: 2013-12-19
Generic name: Coronary drug-eluting stent
Approval order statement: CHANGES RELATED TO THE SOFTWARE USED IN THE MEASUREMENT PROCESS OF THE WAVEFORMS AT THE ¿WAVE FORMING¿ WORK STEP AND THE STENTS AT THE ¿ELECTRO-POLISH¿ WORK STEP.

Current openFDA PMA Record#

Device: RESOLUTE INTEGRITY RX ZOTAROLIMUS-ELUTING CORNARY STENT SYSTEM; RESOLUTE INTEGRITY OTW ZOTAROLINUS ELUTING STENT SYSTEM
Applicant: Medtronic Vascular
PMA number: P110013
Supplement: S031
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2013-12-19
Decision code: OK30
Date received: 2013-11-22
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGES RELATED TO THE SOFTWARE USED IN THE MEASUREMENT PROCESS OF THE WAVEFORMS AT THE ¿WAVE FORMING¿ WORK STEP AND THE STENTS AT THE ¿ELECTRO-POLISH¿ WORK STEP.