PMA P060033S040
- Device
- ENDEAVOR AND ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS
- Applicant
- Medtronic, Inc.
- PMA number
- P060033
- Supplement
- S040
- Product code
- NIQ
- Decision date
- 2009-10-29
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE.
Current openFDA PMA Record
- Device
- ENDEAVOR AND ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS
- Applicant
- Medtronic, Inc.
- PMA number
- P060033
- Supplement
- S040
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2009-10-29
- Decision code
- APPR
- Date received
- 2009-08-14
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE.