PMA P060033S083
- Device
- ENVEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
- Applicant
- Medtronic, Inc.
- PMA number
- P060033
- Supplement
- S083
- Product code
- NIQ
- Decision date
- 2013-12-12
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- CONSOLIDATE AND TRANSFER EXTRUSION ACTIVITIES TO THE SANTA ROSA, CA FACILITY.
Current openFDA PMA Record
- Device
- ENVEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
- Applicant
- Medtronic, Inc.
- PMA number
- P060033
- Supplement
- S083
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2013-12-12
- Decision code
- OK30
- Date received
- 2013-11-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CONSOLIDATE AND TRANSFER EXTRUSION ACTIVITIES TO THE SANTA ROSA, CA FACILITY.