LifeStream® Balloon Expandable Vascular Covered Stent
FDA premarket approval P160024/S012 · decided 2022-08-23
Approval details
- PMA number
- P160024
- Supplement
- S012
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LifeStream® Balloon Expandable Vascular Covered Stent
- Generic name
- Iliac covered stent, arterial
- Applicant
- Bard Peripheral Vascular, Inc.
- Date received
- 2022-02-24
- Decision date
- 2022-08-23
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- PRL
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- 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.
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