PMA P110023S062
- Device
- EverFlex™ Self-expanding Peripheral Stent System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P110023
- Supplement
- S062
- Product code
- NIP
- Decision date
- 2025-10-02
- Classification
- Cardiovascular
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- approval for a new vapor degreaser processing agent used in the manufacturing process
Current openFDA PMA Record#
- Device
- EverFlex™ Self-expanding Peripheral Stent System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P110023
- Supplement
- S062
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2025-10-02
- Decision code
- OK30
- Date received
- 2025-09-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for a new vapor degreaser processing agent used in the manufacturing process