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THERAPY DUAL 8 CARDIAC ABLATION SYSTEM,THERAM 8MM THERMISTER ABLATION CATHETER SAFIRE TX ABLATION CATHETER

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
IRVINE BIOMEDICAL,INC.(IBI)
Trade Name
THERAPY DUAL 8 CARDIAC ABLATION SYSTEM,THERAM 8MM THERMISTER ABLATION CATHETER SAFIRE TX ABLATION CATHETER
Generic Name
catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Decision Date
11/18/2005
Days to Decision
410 days
Decision Code
APPR
FDA Decision
Approval

THERAPY DUAL 8 CARDIAC ABLATION SYSTEM,THERAM 8MM THERMISTER ABLATION CATHETER SAFIRE TX ABLATION CATHETER

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
IRVINE BIOMEDICAL,INC.(IBI)
Trade Name
THERAPY DUAL 8 CARDIAC ABLATION SYSTEM,THERAM 8MM THERMISTER ABLATION CATHETER SAFIRE TX ABLATION CATHETER
Generic Name
catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Decision Date
11/18/2005
Days to Decision
410 days
Decision Code
APPR
FDA Decision
Approval