PMA P070014S010
- Device
- LIFESTENT AND LIFESTENT XL VASCULAR STENT SYSTEMS
- Applicant
- Bard Peripheral Vascular, Inc.
- PMA number
- P070014
- Supplement
- S010
- Product code
- NIP
- Decision date
- 2010-12-23
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- APPROVAL FOR THE LIFESTENT AND LIFESTENT XL VASCULAR STENT SYSTEMS. THE LIFESTENT AND LIFESTENT XL VASCULAR STENT SYSTEMS ARE INTENDED TO IMPROVE LUMINAL DIAMETER IN THE TREATMENT OF SYMPTOMATIC DE-NOVO OR RESTENOTIC LESIONS UP TO 240 MM IN LENGTH IN NATIVE SUPERFICIAL FEMORAL ARTERY (SFA) AND/OR PROXIMAL POPLITEAL ARTERIES WITH REFERENCE VESSEL DIAMETERS RANGING FROM 4.0 ¿ 6.5 MM.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf7/P070014S010B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- LIFESTENT AND LIFESTENT XL VASCULAR STENT SYSTEMS
- Applicant
- Bard Peripheral Vascular, Inc.
- PMA number
- P070014
- Supplement
- S010
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2010-12-23
- Decision code
- APPR
- Date received
- 2010-03-10
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE LIFESTENT AND LIFESTENT XL VASCULAR STENT SYSTEMS. THE LIFESTENT AND LIFESTENT XL VASCULAR STENT SYSTEMS ARE INTENDED TO IMPROVE LUMINAL DIAMETER IN THE TREATMENT OF SYMPTOMATIC DE-NOVO OR RESTENOTIC LESIONS UP TO 240 MM IN LENGTH IN NATIVE SUPERFICIAL FEMORAL ARTERY (SFA) AND/OR PROXIMAL POPLITEAL ARTERIES WITH REFERENCE VESSEL DIAMETERS RANGING FROM 4.0 ¿ 6.5 MM.