PMA P110023S025
- Device
- EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P110023
- Supplement
- S025
- Product code
- NIP
- Decision date
- 2019-03-21
- Classification
- Stent, Superficial Femoral Artery
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- Alternate piece of manufacturing equipment to perform the delivery system tip shaping process.
Current openFDA PMA Record#
- Device
- EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P110023
- Supplement
- S025
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2019-03-21
- Decision code
- OK30
- Date received
- 2019-02-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate piece of manufacturing equipment to perform the delivery system tip shaping process.