PMA P060033S066
- Device
- ENDEAVOR SPRINT ZOTARLIMUS-ELUTING CORONARY STENT SYSTEMS
- Applicant
- Medtronic, Inc.
- PMA number
- P060033
- Supplement
- S066
- Product code
- NIQ
- Decision date
- 2011-10-25
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- APPROVAL FOR A CHANGE TO THE DRUG SPRAY IN-PROCESS CONTROLS.
Current openFDA PMA Record
- Device
- ENDEAVOR SPRINT ZOTARLIMUS-ELUTING CORONARY STENT SYSTEMS
- Applicant
- Medtronic, Inc.
- PMA number
- P060033
- Supplement
- S066
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2011-10-25
- Decision code
- APPR
- Date received
- 2011-07-13
- 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 THE DRUG SPRAY IN-PROCESS CONTROLS.