LifeStream Balloon Expandable Vascular Covered Stent
FDA premarket approval P160024/S007 · decided 2019-09-09
Approval details
- PMA number
- P160024
- Supplement
- S007
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- LifeStream Balloon Expandable Vascular Covered Stent
- Generic name
- Iliac covered stent, arterial
- Applicant
- Bard Peripheral Vascular, Inc.
- Date received
- 2019-06-27
- Decision date
- 2019-09-09
- Days to decision
- 74 days
- Decision code
- APPR
- Product code
- PRL
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- Approval for updates to the LifeStream Balloon Expandable Vascular Covered Stent labeling to incorporate the 3-year results of the BOLSTER Clinical Study.
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