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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Applicant IRVINE BIOMEDICAL, INC. productcode OAD
 
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PMA
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Ampere™ Generator, Ampere™ Remote Control, Ampere™... IRVINE BIOMEDICAL, INC. P060019 S055 11/29/2023
Ampere™ Generator IRVINE BIOMEDICAL, INC. P060019 S054 10/14/2021
Therapy Cool Path IRVINE BIOMEDICAL, INC. P060019 S053 05/18/2021
Therapy Cool Path Ablation Catheter IRVINE BIOMEDICAL, INC. P060019 S052 05/04/2021
Therapy Cool Path IRVINE BIOMEDICAL, INC. P060019 S051 03/24/2021
Therapy Cool Path, Safire BLU, Safire BLU SP, and ... IRVINE BIOMEDICAL, INC. P060019 S050 03/12/2021
Therapy Cool Path, Safire BLU, Safire BLU SP, and ... IRVINE BIOMEDICAL, INC. P060019 S048 11/02/2020
Therapy Cool Path SP Ablation Catheter IRVINE BIOMEDICAL, INC. P060019 S049 10/16/2020
Therapy Cool Path Ablation Catheter (including all... IRVINE BIOMEDICAL, INC. P060019 S047 04/24/2020
Therapy Cool Path Ablation Catheter IRVINE BIOMEDICAL, INC. P060019 S046 03/04/2020
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