PMA P070014S006

Device: LIFESTENT AND LIFESYENT XL VASCULAR STENT SYSTEMS
Applicant: Bard Peripheral Vascular, Inc.
PMA number: P070014
Supplement: S006
Product code: NIP
Decision date: 2009-12-08
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Approval order statement: APPROVAL FOR THE PROPOSED CHANGE IN PRODUCT LABELING THAT AFFECTS THE STENT DEPLOYMENT PROCEDURES WITHIN THE INSTRUCTIONS FOR USE.

Current openFDA PMA Record#

Device: LIFESTENT AND LIFESYENT XL VASCULAR STENT SYSTEMS
Applicant: Bard Peripheral Vascular, Inc.
PMA number: P070014
Supplement: S006
Product code: NIP
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Decision date: 2009-12-08
Decision code: APPR
Date received: 2009-11-20
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE PROPOSED CHANGE IN PRODUCT LABELING THAT AFFECTS THE STENT DEPLOYMENT PROCEDURES WITHIN THE INSTRUCTIONS FOR USE.