LifeStream Balloon Expandable Vascular Covered Stent
FDA premarket approval P160024/S003 · decided 2018-10-11
Approval details
- PMA number
- P160024
- Supplement
- S003
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process 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
- 2018-03-16
- Decision date
- 2018-10-11
- Days to decision
- 209 days
- Decision code
- APPR
- Product code
- PRL
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- Adding a sterilization line at the Bard Regional Sterilization, Madison Facility.
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