LifeStream Balloon Expandable Vascular Covered Stent
FDA premarket approval P160024/S011 · decided 2022-02-11
Approval details
- PMA number
- P160024
- Supplement
- S011
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LifeStream Balloon Expandable Vascular Covered Stent
- Generic name
- Iliac covered stent, arterial
- Applicant
- Bard Peripheral Vascular, Inc.
- Date received
- 2021-09-30
- Decision date
- 2022-02-11
- Days to decision
- 134 days
- Decision code
- APPR
- Product code
- PRL
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- Approval for modifying the materials of the packaging sterile barrier.
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