PMA P060033S075
- Device
- Endeavor Sprint Zotarolimus-eluting Coronary Stent
- Applicant
- MEDTRONIC Inc.
- PMA number
- P060033
- Supplement
- S075
- Decision date
- 2013-10-15
Current openFDA PMA Record
- Device
- ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
- Applicant
- Medtronic, Inc.
- PMA number
- P060033
- Supplement
- S075
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2013-10-15
- Decision code
- APPR
- Date received
- 2013-04-26
- Supplement type
- 135 Review Track For 30-Day Notice
- Approval order statement
- APPROVAL FOR A CHANGE TO THE EMPOWER SOFTWARE APPLICATION USED TO CONTROL THE ANALYTICAL CHROMATOGRAPHIC INSTRUMENTS FOR THE ANALYTICAL TESTS.