PMA P110013S062
- Device
- RESOLUTE MICROTRAC/RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
- Applicant
- Medtronic Vascular
- PMA number
- P110013
- Supplement
- S062
- Product code
- NIQ
- Decision date
- 2016-03-31
- Classification
- Coronary Drug-eluting Stent
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Change to the ethylene oxide sterilization monitoring process.
Current openFDA PMA Record#
- Device
- RESOLUTE MICROTRAC/RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
- Applicant
- Medtronic Vascular
- PMA number
- P110013
- Supplement
- S062
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2016-03-31
- Decision code
- OK30
- Date received
- 2016-03-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the ethylene oxide sterilization monitoring process.