LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT
FDA premarket approval P160024 · decided 2017-04-24
Approval details
- PMA number
- P160024
- Trade name
- LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT
- Generic name
- Iliac covered stent, arterial
- Applicant
- Bard Peripheral Vascular, Inc.
- Date received
- 2016-07-21
- Decision date
- 2017-04-24
- Days to decision
- 277 days
- Decision code
- APPR
- Product code
- PRL
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- Approval for the LifeStream Balloon Expandable Vascular Covered Stent. This device is indicated for the treatment of atherosclerotic lesions in common and external iliac arteries with reference vessel diameters between 4.5 mm and 12.0 mm, and lesion lengths up to 100 mm.
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