PMA P060033S068
- Device
- Endeavor Sprint Coronary Stent Systems
- Applicant
- MEDTRONIC Inc.
- PMA number
- P060033
- Supplement
- S068
- Decision date
- 2011-10-19
Current openFDA PMA Record
- Device
- ENDEAVOR SPRINT CORONARY STENT SYSTEMS
- Applicant
- Medtronic, Inc.
- PMA number
- P060033
- Supplement
- S068
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2011-10-19
- Decision code
- OK30
- Date received
- 2011-09-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGING THE PRODUCT PRINT INFORMATION FROM A MANUAL PROCESS TO AN AUTOMATED PROCESS.