Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | LifeStream Balloon Expandable Vascular Covered Stent |
Generic Name | Iliac covered stent, arterial |
Applicant | BARD PERIPHERAL VASCULAR, INC. 1625 WEST 3RD ST. TEMPE, AZ 85281-1740 |
PMA Number | P160024 |
Supplement Number | S001 |
Date Received | 06/19/2017 |
Decision Date | 07/19/2017 |
Product Code |
PRL |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Upgrade the sterilization control system for sterilization line #1 at Bard Regional Sterilization, Covington Facility. |
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