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DYNAGEN™ ICD Models D150, D151, D152, D153; INOGEN™ ICD Models D140,

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
BOSTON SCIENTIFIC
Trade Name
VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM
Generic Name
Implantable cardioverter defibrillator (non-CRT)
Decision Date
7/18/1997
Days to Decision
332 days
Decision Code
APPR
FDA Decision
Approval

DYNAGEN™ ICD Models D150, D151, D152, D153; INOGEN™ ICD Models D140,

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
BOSTON SCIENTIFIC
Trade Name
VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM
Generic Name
Implantable cardioverter defibrillator (non-CRT)
Decision Date
7/18/1997
Days to Decision
332 days
Decision Code
APPR
FDA Decision
Approval