PMA P880006S093

Device: SENSOLOG / DIALOG/ REGENCY FAMILY OF PACEMAKERS
Applicant: St. Jude Medical, Inc.
PMA number: P880006
Supplement: S093
Product code: NIK
Decision date: 2015-08-27
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Approval order statement: APPROVAL FOR THE NEW ENDURITY CORE FAMILY OF PACEMAKERS, THE MERLIN 20.1.1 PCS PROGRAMMER SOFTWARE WHICH SUPPORTS THE NEW DEVICE MODELS, UPDATED MERLINCONDUCT 1.3 MOBILE APPLICATION SOFTWARE, AND SUPPORT FOR THE MERLIN ELECTRONIC HEALTH RECORD DIRECTEXPORT FEATURE.

Current openFDA PMA Record

Device: SENSOLOG / DIALOG/ REGENCY FAMILY OF PACEMAKERS
Applicant: St. Jude Medical, Inc.
PMA number: P880006
Supplement: S093
Product code: NIK
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Decision date: 2015-08-27
Decision code: APPR
Date received: 2015-02-11
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE NEW ENDURITY CORE FAMILY OF PACEMAKERS, THE MERLIN 20.1.1 PCS PROGRAMMER SOFTWARE WHICH SUPPORTS THE NEW DEVICE MODELS, UPDATED MERLINCONDUCT 1.3 MOBILE APPLICATION SOFTWARE, AND SUPPORT FOR THE MERLIN ELECTRONIC HEALTH RECORD DIRECTEXPORT FEATURE.