PMA P070015S145
- Device
- XIENCE V Everolimus Eluting Coronary Stent Systemand XIENCE nano Everolimus Eluting Coronary Stent System
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P070015
- Supplement
- S145
- Product code
- NIQ
- Decision date
- 2019-07-12
- Classification
- Coronary Drug-eluting Stent
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Changes to the gowning regime and reclassification of the manufacturing environment.
Current openFDA PMA Record#
- Device
- XIENCE V Everolimus Eluting Coronary Stent Systemand XIENCE nano Everolimus Eluting Coronary Stent System
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P070015
- Supplement
- S145
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2019-07-12
- Decision code
- OK30
- Date received
- 2019-06-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the gowning regime and reclassification of the manufacturing environment.