LifeStream Balloon Expandable Vascular Covered Stent
FDA premarket approval P160024/S001 · decided 2017-07-19
Approval details
- PMA number
- P160024
- Supplement
- S001
- Supplement type
- 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
- 2017-06-19
- Decision date
- 2017-07-19
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- PRL
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- Upgrade the sterilization control system for sterilization line #1 at Bard Regional Sterilization, Covington Facility.
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