PMA P060033S067
- Device
- Endeavor Sprint Zotarolimus-eluting Coronary Stent
- Applicant
- MEDTRONIC Inc.
- PMA number
- P060033
- Supplement
- S067
- Decision date
- 2011-09-30
Current openFDA PMA Record
- Device
- ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS
- Applicant
- Medtronic, Inc.
- PMA number
- P060033
- Supplement
- S067
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2011-09-30
- Decision code
- APPR
- Date received
- 2011-08-01
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR A SHELF LIFE EXTENSION FROM TWO YEARS TO THREE YEARS FOR THE DEVICE.