PMA P880006S073

Device: SENSOLOG/DIALOG/REGENCY FAMILY OF CRT-PS
Applicant: St. Jude Medical, Inc.
PMA number: P880006
Supplement: S073
Product code: LWP
Decision date: 2011-09-08
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Approval order statement: APPROVAL FOR MODEL 3330 VERSION 13.1 PROGRAMMER SOFTWARE WHICH INCLUDES ENHANCEMENTS TO THE LAYOUT/DESIGN OF THE EXISTING MERLIN PCS PRINTED REPORTS.

Current openFDA PMA Record

Device: SENSOLOG/DIALOG/REGENCY FAMILY OF CRT-PS
Applicant: St. Jude Medical, Inc.
PMA number: P880006
Supplement: S073
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Decision date: 2011-09-08
Decision code: APPR
Date received: 2011-08-08
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR MODEL 3330 VERSION 13.1 PROGRAMMER SOFTWARE WHICH INCLUDES ENHANCEMENTS TO THE LAYOUT/DESIGN OF THE EXISTING MERLIN PCS PRINTED REPORTS.