PMA P060033S063
- Device
- Endeavor Zotarolimus-eluting Coronary Stent System
- Applicant
- MEDTRONIC Inc.
- PMA number
- P060033
- Supplement
- S063
- Decision date
- 2011-04-20
Current openFDA PMA Record
- Device
- ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS
- Applicant
- Medtronic, Inc.
- PMA number
- P060033
- Supplement
- S063
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2011-04-20
- Decision code
- APPR
- Date received
- 2011-01-07
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A MODIFICATION TO THE REGULATORY ELUTION SPECIFICATION. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM AND IS INDICATED FOR IMPROVING LUMINAL DIAMETER.