PMA P160024S012

Device: LifeStream® Balloon Expandable Vascular Covered Stent
Applicant: Bard Peripheral Vascular, Inc.
PMA number: P160024
Supplement: S012
Product code: PRL
Decision date: 2022-08-23
Generic name: Iliac covered stent, arterial
Approval order statement: Approval for a manufacturing site located at Angiomed GmbH & Co. Medizintechnik KG, Wachhausstrasse 6, Karlsruhe Baden-Wurttemberg 76227, Germany for supplying the bare metal stent component.

Current openFDA PMA Record#

Device: LifeStream® Balloon Expandable Vascular Covered Stent
Applicant: Bard Peripheral Vascular, Inc.
PMA number: P160024
Supplement: S012
Product code: PRL
Generic name: Iliac covered stent, arterial
Decision date: 2022-08-23
Decision code: APPR
Date received: 2022-02-24
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a manufacturing site located at Angiomed GmbH & Co. Medizintechnik KG, Wachhausstrasse 6, Karlsruhe Baden-Wurttemberg 76227, Germany for supplying the bare metal stent component.