PMA P060033S072

Device: ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS
Applicant: Medtronic, Inc.
PMA number: P060033
Supplement: S072
Product code: NIQ
Decision date: 2012-11-20
Generic name: Coronary drug-eluting stent
Approval order statement: CHANGES TO THE ORIENTATION OF THE STERILIZATION CARTONS, LOCATION OF THE INTERNAL PROCESS CHALLENGE DEVICES, AND MODIFICATIONS TO THE EXTERNAL PROCESS CHALLENGE DEVICES USED DURING STERILIZATION.

Current openFDA PMA Record

Device: ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS
Applicant: Medtronic, Inc.
PMA number: P060033
Supplement: S072
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2012-11-20
Decision code: OK30
Date received: 2012-10-03
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGES TO THE ORIENTATION OF THE STERILIZATION CARTONS, LOCATION OF THE INTERNAL PROCESS CHALLENGE DEVICES, AND MODIFICATIONS TO THE EXTERNAL PROCESS CHALLENGE DEVICES USED DURING STERILIZATION.