PMA P060033S077
- Device
- ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
- Applicant
- Medtronic, Inc.
- PMA number
- P060033
- Supplement
- S077
- Product code
- NIQ
- Decision date
- 2013-07-10
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- UPGRADE TO THE SPRAY WEIGH AUTOMATED SYSTEM (SWAT III) AND SPRAYER CURRENTLY USED ON THE RESOLUTE INTEGRITY AND ENDEAVOR SPRINT DEVICES.
Current openFDA PMA Record
- Device
- ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
- Applicant
- Medtronic, Inc.
- PMA number
- P060033
- Supplement
- S077
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2013-07-10
- Decision code
- OK30
- Date received
- 2013-05-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- UPGRADE TO THE SPRAY WEIGH AUTOMATED SYSTEM (SWAT III) AND SPRAYER CURRENTLY USED ON THE RESOLUTE INTEGRITY AND ENDEAVOR SPRINT DEVICES.