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THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
St. Jude Medical, Inc. (Irvine Biomedical)
Trade Name
THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR
Generic Name
catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Decision Date
1/25/2012
Days to Decision
285 days
Decision Code
APPR
FDA Decision
Approval

THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
St. Jude Medical, Inc. (Irvine Biomedical)
Trade Name
THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR
Generic Name
catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Decision Date
1/25/2012
Days to Decision
285 days
Decision Code
APPR
FDA Decision
Approval