PMA P110023S028
- Device
- EverFlex Self-Expanding Peripheral Stent Systems and EverFlex Self-Expanding Peripheral Stent with Entrust Delivery Syst
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P110023
- Supplement
- S028
- Product code
- NIP
- Decision date
- 2019-11-20
- Classification
- Stent, Superficial Femoral Artery
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- Approval for labeling updates with the final results of the DURABILITY post-approval study.
Current openFDA PMA Record#
- Device
- EverFlex Self-Expanding Peripheral Stent Systems and EverFlex Self-Expanding Peripheral Stent with Entrust Delivery Syst
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P110023
- Supplement
- S028
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2019-11-20
- Decision code
- APPR
- Date received
- 2019-08-27
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for labeling updates with the final results of the DURABILITY post-approval study.