PMA P060033S088
- Device
- ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
- Applicant
- Medtronic, Inc.
- PMA number
- P060033
- Supplement
- S088
- Product code
- NIQ
- Decision date
- 2014-03-04
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- APPROVAL FOR A RECONCILIATION PROCESS FOR COMPLIANCE CHART LABELS.
Current openFDA PMA Record
- Device
- ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
- Applicant
- Medtronic, Inc.
- PMA number
- P060033
- Supplement
- S088
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2014-03-04
- Decision code
- APPR
- Date received
- 2014-02-03
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A RECONCILIATION PROCESS FOR COMPLIANCE CHART LABELS.