PMA P060033S057
- Device
- ENDEAVOR ZOTAROLIMUS-ELUTING STENT SYSTEM
- Applicant
- Medtronic, Inc.
- PMA number
- P060033
- Supplement
- S057
- Product code
- NIQ
- Decision date
- 2010-09-01
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- CHANGE TO STERILIZATION LOAD CONFIGURATION.
Current openFDA PMA Record
- Device
- ENDEAVOR ZOTAROLIMUS-ELUTING STENT SYSTEM
- Applicant
- Medtronic, Inc.
- PMA number
- P060033
- Supplement
- S057
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2010-09-01
- Decision code
- OK30
- Date received
- 2010-08-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO STERILIZATION LOAD CONFIGURATION.