PMA P060033S043
- Device
- ENDEAVOR/ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
- Applicant
- Medtronic, Inc.
- PMA number
- P060033
- Supplement
- S043
- Product code
- NIQ
- Decision date
- 2010-12-10
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- APPROVAL FOR AN UPDATE TO ABBOTT LABORATORIES¿ DRUG COMPONENT.
Current openFDA PMA Record
- Device
- ENDEAVOR/ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
- Applicant
- Medtronic, Inc.
- PMA number
- P060033
- Supplement
- S043
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2010-12-10
- Decision code
- APPR
- Date received
- 2009-09-08
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR AN UPDATE TO ABBOTT LABORATORIES¿ DRUG COMPONENT.