PMA P060033S069
- Device
- ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
- Applicant
- Medtronic, Inc.
- PMA number
- P060033
- Supplement
- S069
- Product code
- NIQ
- Decision date
- 2012-07-31
- Generic name
- Coronary drug-eluting stent
- 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).
Current openFDA PMA Record
- Device
- ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
- Applicant
- Medtronic, Inc.
- PMA number
- P060033
- Supplement
- S069
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2012-07-31
- Decision code
- APPR
- Date received
- 2012-03-19
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- 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).