PMA P880006S081

Device: SENSOLOG/ DIALOG/REGENCY FAMILY OF PACEMAKERS
Applicant: St. Jude Medical, Inc.
PMA number: P880006
Supplement: S081
Product code: LWP
Decision date: 2014-04-10
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Approval order statement: APPROVAL FOR THE MERLIN CONDUCT MOBILE SOFTWARE APPLICATION AND MODEL 3330 VERSION 16.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM FOR THE DEVICES.

Current openFDA PMA Record

Device: SENSOLOG/ DIALOG/REGENCY FAMILY OF PACEMAKERS
Applicant: St. Jude Medical, Inc.
PMA number: P880006
Supplement: S081
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Decision date: 2014-04-10
Decision code: APPR
Date received: 2012-07-11
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE MERLIN CONDUCT MOBILE SOFTWARE APPLICATION AND MODEL 3330 VERSION 16.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM FOR THE DEVICES.