PMA P830045S087

Device: ADX PULSE GENERATOR
Applicant: St. Jude Medical, Inc.
PMA number: P830045
Supplement: S087
Product code: KRG
Decision date: 2003-08-15
Classification: Cardiovascular
Generic name: Programmer, pacemaker
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE FIRMWARE OF THE ADX FAMILY OF PULSE GENERATORS AND FOR PROGRAMMING SOFTWARE MODEL 3307 V4.4.2A TO IMPLEMENT THE MODIFIED FIRMWARE IN IMPLANTED DEVICES.

Current openFDA PMA Record#

Device: ADX PULSE GENERATOR
Applicant: St. Jude Medical, Inc.
PMA number: P830045
Supplement: S087
Product code: KRG
Generic name: Programmer, pacemaker
Decision date: 2003-08-15
Decision code: APPR
Date received: 2003-08-05
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE FIRMWARE OF THE ADX FAMILY OF PULSE GENERATORS AND FOR PROGRAMMING SOFTWARE MODEL 3307 V4.4.2A TO IMPLEMENT THE MODIFIED FIRMWARE IN IMPLANTED DEVICES.