PMA P060033S071
- Device
- Endeaovor Sprint Zotarolimus-eluting Coronary Sten
- Applicant
- MEDTRONIC Inc.
- PMA number
- P060033
- Supplement
- S071
- Decision date
- 2012-08-31
Current openFDA PMA Record
- Device
- ENDEAOVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS
- Applicant
- Medtronic, Inc.
- PMA number
- P060033
- Supplement
- S071
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2012-08-31
- Decision code
- OK30
- Date received
- 2012-08-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MANUFACTURING EQUIPMENT CHANGE TO THE INITIAL CRIMP STENT PROCESS.