PMA P110013S025
- Device
- RESOLUTE INTEGRITY CORONARY STENT SYSTEM
- Applicant
- Medtronic Vascular
- PMA number
- P110013
- Supplement
- S025
- Product code
- NIQ
- Decision date
- 2013-09-18
- Classification
- Coronary Drug-eluting Stent
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- CHANGE TO THE LABELING INSPECTION PROCESS.
Current openFDA PMA Record#
- Device
- RESOLUTE INTEGRITY CORONARY STENT SYSTEM
- Applicant
- Medtronic Vascular
- PMA number
- P110013
- Supplement
- S025
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2013-09-18
- Decision code
- OK30
- Date received
- 2013-08-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE LABELING INSPECTION PROCESS.