PMA P060033S064
- Device
- Endeavor Sprint Zotarolimus-eluting Coronary Stent
- Applicant
- MEDTRONIC Inc.
- PMA number
- P060033
- Supplement
- S064
- Decision date
- 2011-06-02
Current openFDA PMA Record
- Device
- ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
- Applicant
- Medtronic, Inc.
- PMA number
- P060033
- Supplement
- S064
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2011-06-02
- Decision code
- APPR
- Date received
- 2011-03-01
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE (WITH THE LATEST AVAILABLE FOLLOW-UP CLINICAL DATA FROM THE ENDEAVOR CLINICAL TRIAL PROGRAMS).