PMA P060033S046
- Device
- ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
- Applicant
- Medtronic, Inc.
- PMA number
- P060033
- Supplement
- S046
- Product code
- NIQ
- Decision date
- 2010-06-11
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- APPROVAL FOR A CHANGE TO REMOVE THE FUNCTIONAL TEST FROM THE QUALITY RELEASE SPECIFICATION.
Current openFDA PMA Record
- Device
- ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
- Applicant
- Medtronic, Inc.
- PMA number
- P060033
- Supplement
- S046
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2010-06-11
- Decision code
- APPR
- Date received
- 2009-12-24
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A CHANGE TO REMOVE THE FUNCTIONAL TEST FROM THE QUALITY RELEASE SPECIFICATION.