PMA P060033S085
- Device
- Endeavor Sprint Zotarolimus-eluting Coronary Stent
- Applicant
- MEDTRONIC Inc.
- PMA number
- P060033
- Supplement
- S085
- Decision date
- 2014-01-14
Current openFDA PMA Record
- Device
- ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
- Applicant
- Medtronic, Inc.
- PMA number
- P060033
- Supplement
- S085
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2014-01-14
- Decision code
- OK30
- Date received
- 2013-12-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO YOUR BIOBURDEN TEST METHOD.