PMA P830045S078

Device: INTEGRITY AFX DR MODEL 5346
Applicant: St. Jude Medical, Inc.
PMA number: P830045
Supplement: S078
Product code: KRG
Decision date: 2001-10-02
Classification: Cardiovascular
Generic name: Programmer, pacemaker
Approval order statement: APPROVAL FOR THE MODEL 3307 V2.4.1A PROGRAMMER SOFTWARE WHICH ALLOWS FOR THE INTEGRITY AFX DR MODEL 5342 AND INTEGRITY U DR MODEL 5336 TO ACCESS THE DYNAMIC ATRIAL OVERDRIVE (DAO) AND ADVANCED HYSTERESIS FEATURES.

Current openFDA PMA Record#

Device: INTEGRITY AFX DR MODEL 5346
Applicant: St. Jude Medical, Inc.
PMA number: P830045
Supplement: S078
Product code: KRG
Generic name: Programmer, pacemaker
Decision date: 2001-10-02
Decision code: APPR
Date received: 2001-09-05
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE MODEL 3307 V2.4.1A PROGRAMMER SOFTWARE WHICH ALLOWS FOR THE INTEGRITY AFX DR MODEL 5342 AND INTEGRITY U DR MODEL 5336 TO ACCESS THE DYNAMIC ATRIAL OVERDRIVE (DAO) AND ADVANCED HYSTERESIS FEATURES.