PMA P070014S060
- Device
- LifeStent Vascular Stent Systems
- Applicant
- Bard Peripheral Vascular, Inc.
- Product code
- NIP
- Decision date
- 2021-05-19
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- Approval an alternate supplier for the primary and secondary sheath components of the LifeStent Vascular Stent Systems.
Current openFDA PMA Record#
- Device
- LifeStent Vascular Stent Systems
- Applicant
- Bard Peripheral Vascular, Inc.
- PMA number
- P070014
- Supplement
- S060
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2021-05-19
- Decision code
- APPR
- Date received
- 2020-05-21
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval an alternate supplier for the primary and secondary sheath components of the LifeStent Vascular Stent Systems.