PMA approvals

Liverty™ TIPS Stent Graft

Bard Peripheral Vascular, Inc. · SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS · Cardiovascular

P250050 S001SupplementOK30
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PMA number
P250050
Supplement number
S001
Applicant
Bard Peripheral Vascular, Inc.
Street 1
1625 W. 3rd St.
City
Tempe
State
AZ
Zip
85281
Generic name
SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
Trade name
Liverty™ TIPS Stent Graft
Product code
MIR
Advisory committee
CV
Advisory committee description
Cardiovascular
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited review flag
N
Date received
2026-09-28
Decision date
2026-10-23
Decision code
OK30
Ao statement
modification to the manufacturing process of the inner ePTFE covering material of the Bard Liverty TIPS Stent Graft
Harmonized identifiers (openFDA)
Device name
Shunt, Portosystemic, Endoprosthesis
Medical specialty description
Unknown
Device class
3
Registration number
2020394, 3007284313, 9681260, 9681442, 1000121056, 2124215, 3010273872, 1721676, 2011171, 3002807314, 3005111382, 3002504068
FEI number
2020394, 3007284313, 3002806368, 1000121056, 3002806565, 2124215, 3010273872, 1721676, 2011171, 3002807314, 3005111382, 3002504068
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.