Last synced on 27 June 2025 at 11:06 pm

BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
Trade Name
CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION
Generic Name
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Decision Date
6/26/2002
Days to Decision
418 days
Decision Code
APPR
FDA Decision
Approval

BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
Trade Name
CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION
Generic Name
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Decision Date
6/26/2002
Days to Decision
418 days
Decision Code
APPR
FDA Decision
Approval