The differential pressure sensor in certain Impella devices may malfunction and cause sensor values to drift.
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CDER Data Standards ProgramWedgewood Connect, LLC. San Jose, CA. 483 issued 07/03/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 07/03/2025
Short Title (70 char) Wedgewood Connect, LLC. San Jose, CA. 483 issued 07/03/2025
FEI Number 3003434972
Firm Name Wedgewood Connect, LLC
Record Type 483
State CA
Establishment Type Outsourcing FacilitOTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2025 User Fees and Registration – 05/20/2025
OTC Monograph Drug User Fee Program (OMUFA); Understanding FY 2025 User Fees and Registration
