PMA P060033S090
- Device
- ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSEM
- Applicant
- Medtronic, Inc.
- PMA number
- P060033
- Supplement
- S090
- Product code
- NIQ
- Decision date
- 2014-04-09
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- EXTENSION TO THE RETEST PERIOD FOR ZOTAROLIMUS FROM 12 MONTHS TO 24 MONTHS.
Current openFDA PMA Record
- Device
- ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSEM
- Applicant
- Medtronic, Inc.
- PMA number
- P060033
- Supplement
- S090
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2014-04-09
- Decision code
- OK30
- Date received
- 2014-03-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- EXTENSION TO THE RETEST PERIOD FOR ZOTAROLIMUS FROM 12 MONTHS TO 24 MONTHS.