PMA P070014S056
- Device
- LifeStent 5mm Vascular Stent System
- Applicant
- Bard Peripheral Vascular, Inc.
- PMA number
- P070014
- Supplement
- S056
- Product code
- NIP
- Decision date
- 2018-06-20
- Classification
- Stent, Superficial Femoral Artery
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- Implementation of a reloading process for 5mm diameter stents.
Current openFDA PMA Record#
- Device
- LifeStent 5mm Vascular Stent System
- Applicant
- Bard Peripheral Vascular, Inc.
- PMA number
- P070014
- Supplement
- S056
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2018-06-20
- Decision code
- OK30
- Date received
- 2018-06-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of a reloading process for 5mm diameter stents.