LIFESTENT AND LIFESTENT XL VASCULAR STENT SYSTEMS
FDA premarket approval P070014/S001 · decided 2009-07-30
Approval details
- PMA number
- P070014
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- LIFESTENT AND LIFESTENT XL VASCULAR STENT SYSTEMS
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Bard Peripheral Vascular, Inc.
- Date received
- 2009-06-02
- Decision date
- 2009-07-30
- Days to decision
- 58 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- APPROVAL TO MODIFY THE NAME AND PACKAGE LABEL FOR THE LIFESTENTVASCULAR STENT SYSTEMS. SPECIFICALLY, THE WORD "FLEXSTAR" WILL BE REMOVED FROM THE TRADE NAMEAND "& BILIARY" WILL BE ADDED TO THE DEVICE PACKAGE LABELS TO REFLECT THE CLEARED BILIARY INDICATION FOR THIS DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LIFESTENTVASCULAR STENT SYSTEM AND LIFESTENT XL VASCULAR STENT SYSTEM AND IS INDICATED FORIMPROVEMENT OF LUMINAL DIAMETER IN THE TREATMENT OF DE-NOVO OR RESTENOTIC
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.