PMA P060033S033
- Device
- Endeavor Zotarolimus & Sprint Zotarolimus-eluting
- Applicant
- MEDTRONIC Inc.
- PMA number
- P060033
- Supplement
- S033
- Decision date
- 2009-11-13
Current openFDA PMA Record
- Device
- ENDEAVOR ZOTAROLIMUS & SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
- Applicant
- Medtronic, Inc.
- PMA number
- P060033
- Supplement
- S033
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2009-11-13
- Decision code
- APPR
- Date received
- 2009-02-13
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MODIFICATION IN THE PREPARATION OF TEST EXTRACTS.