PMA P060033S092

Device: ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
Applicant: Medtronic, Inc.
PMA number: P060033
Supplement: S092
Product code: NIQ
Decision date: 2014-10-17
Generic name: Coronary drug-eluting stent
Approval order statement: APPROVAL OF UPDATES TO THE INSTRUCTIONS FOR USE TO ACCURATELY REFLECT THE CORRECT SAFETY FACTORS FOR THE ZOTAROLIMUS DRUG SUBSTANCE.

Current openFDA PMA Record

Device: ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
Applicant: Medtronic, Inc.
PMA number: P060033
Supplement: S092
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2014-10-17
Decision code: APPR
Date received: 2014-07-22
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL OF UPDATES TO THE INSTRUCTIONS FOR USE TO ACCURATELY REFLECT THE CORRECT SAFETY FACTORS FOR THE ZOTAROLIMUS DRUG SUBSTANCE.