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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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11 to 20 of 42 Results
Applicant IRVINE BIOMEDICAL, INC. productcode OAD Decision Date To 04/18/2024
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PMA
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Cool Point Irrigation Pump IRVINE BIOMEDICAL, INC. P060019 S043 08/16/2019
Therapy Cool Path Ablation Catheter IRVINE BIOMEDICAL, INC. P060019 S045 04/11/2019
Therapy Cool Path, Safire BLU, Safire BLU SP, Ther... IRVINE BIOMEDICAL, INC. P060019 S044 01/10/2019
Therapy Cool Path, Safire BLU, Safire BLU SP, Ther... IRVINE BIOMEDICAL, INC. P060019 S042 03/06/2018
Cool Point Tubing Set IRVINE BIOMEDICAL, INC. P060019 S041 11/02/2017
Therapy Cool Path Ablation Catheters, Therapy Cool... IRVINE BIOMEDICAL, INC. P060019 S039 05/19/2017
Therapy Cool Path Ablation Catheters IRVINE BIOMEDICAL, INC. P060019 S038 09/08/2016
THERAPY COOL PATH ABLATION CATHETER, THERAPY COOL ... IRVINE BIOMEDICAL, INC. P060019 S037 06/24/2016
IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500... IRVINE BIOMEDICAL, INC. P060019 S036 02/29/2016
COOL POINT(TM) TUBING SET IRVINE BIOMEDICAL, INC. P060019 S025 05/19/2014
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