PMA P880006S078

Device: SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS
Applicant: St. Jude Medical, Inc.
PMA number: P880006
Supplement: S078
Product code: NIK
Decision date: 2012-03-21
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Approval order statement: APPROVAL FOR THE MODEL 3330 VERSION 13.1.0 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM TO BE USED WITH THE SENSOLOG/ DIALOG/REGENCY FAMILY OF PACEMAKERS.

Current openFDA PMA Record

Device: SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS
Applicant: St. Jude Medical, Inc.
PMA number: P880006
Supplement: S078
Product code: NIK
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Decision date: 2012-03-21
Decision code: APPR
Date received: 2012-02-29
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE MODEL 3330 VERSION 13.1.0 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM TO BE USED WITH THE SENSOLOG/ DIALOG/REGENCY FAMILY OF PACEMAKERS.