PMA P060033S081

Device: ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
Applicant: Medtronic, Inc.
PMA number: P060033
Supplement: S081
Product code: NIQ
Decision date: 2013-10-24
Generic name: Coronary drug-eluting stent
Approval order statement: ADDITION OF OPTICAL SENSORS TO THE GLASS SCALE OF THE FLOW METER AT THE SPECIFICATION LIMITS TO ASSIST THE OPERATOR IN ACCEPTING/ REJECTING THE HYPOTUBE UNDER INSPECTION.

Current openFDA PMA Record

Device: ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
Applicant: Medtronic, Inc.
PMA number: P060033
Supplement: S081
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2013-10-24
Decision code: OK30
Date received: 2013-09-26
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ADDITION OF OPTICAL SENSORS TO THE GLASS SCALE OF THE FLOW METER AT THE SPECIFICATION LIMITS TO ASSIST THE OPERATOR IN ACCEPTING/ REJECTING THE HYPOTUBE UNDER INSPECTION.