PMA P070015
- Device
- XIENCE V Everolimus Eluting Coronary Stent System
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P070015
- Supplement
- S148
- Product code
- NIQ
- Decision date
- 2021-03-24
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Change to the sub-assembly stent inspection process to increase manufacturing efficiency.
Current openFDA PMA Record#
- Device
- XIENCE V Everolimus Eluting Coronary Stent System
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P070015
- Supplement
- S148
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2021-03-24
- Decision code
- OK30
- Date received
- 2021-02-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the sub-assembly stent inspection process to increase manufacturing efficiency.