PMA P060033S061
- Device
- Endeavor Sprint Coronary Stent System
- Applicant
- MEDTRONIC Inc.
- PMA number
- P060033
- Supplement
- S061
- Decision date
- 2011-04-12
Current openFDA PMA Record
- Device
- ENDEAVOR SPRINT CORONARY STENT SYSTEM
- Applicant
- Medtronic, Inc.
- PMA number
- P060033
- Supplement
- S061
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2011-04-12
- Decision code
- APPR
- Date received
- 2010-12-10
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL TO EXTEND THE SCOPE OF THE RECEIVING AND MANUFACTURING ACTIVITIES CONDUCTED AT A THIRD PARTY STORAGE LOCATION.