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ACUITY X4 STRAIGHT (4671,4672), SPIRAL S (4674,4675), SPIRAL L (4677,4678) LEADS; SUTURELESS SLEEVE & FLUSHING TOOL/WIRE

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
Boston Scientific Corp.
Trade Name
CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL
Generic Name
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Decision Date
5/2/2002
Days to Decision
429 days
Decision Code
APPR
FDA Decision
Approval

ACUITY X4 STRAIGHT (4671,4672), SPIRAL S (4674,4675), SPIRAL L (4677,4678) LEADS; SUTURELESS SLEEVE & FLUSHING TOOL/WIRE

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
Boston Scientific Corp.
Trade Name
CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL
Generic Name
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Decision Date
5/2/2002
Days to Decision
429 days
Decision Code
APPR
FDA Decision
Approval