PMA P070014S061
- Device
- LifeStent 5F Vascular Stent Systems
- Applicant
- Bard Peripheral Vascular, Inc.
- PMA number
- P070014
- Supplement
- S061
- Product code
- NIP
- Decision date
- 2020-09-25
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- Alternate supplier of delivery system handle lock marking and thermoplastic staking processes.
Current openFDA PMA Record#
- Device
- LifeStent 5F Vascular Stent Systems
- Applicant
- Bard Peripheral Vascular, Inc.
- PMA number
- P070014
- Supplement
- S061
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2020-09-25
- Decision code
- OK30
- Date received
- 2020-08-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate supplier of delivery system handle lock marking and thermoplastic staking processes.