PMA P070014S057
- Device
- LifeStent 5F Vascular Stent System
- Applicant
- Bard Peripheral Vascular, Inc.
- PMA number
- P070014
- Supplement
- S057
- Product code
- NIP
- Decision date
- 2018-08-06
- Classification
- Stent, Superficial Femoral Artery
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- Removal of an in-process manufacturing inspection for stent pushing force.
Current openFDA PMA Record#
- Device
- LifeStent 5F Vascular Stent System
- Applicant
- Bard Peripheral Vascular, Inc.
- PMA number
- P070014
- Supplement
- S057
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2018-08-06
- Decision code
- OK30
- Date received
- 2018-07-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Removal of an in-process manufacturing inspection for stent pushing force.