PMA P880086S095

Device: ADX PULSE GENERATOR FIRMWARE ANOMALY CORRECTION
Applicant: ABBOTT MEDICAL
PMA number: P880086
Supplement: S095
Product code: DXY
Decision date: 2003-08-15
Classification: Implantable Pacemaker Pulse-generator
Generic name: implantable pacemaker Pulse-generator
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 FIRMWARE ANOMALY CORRECTION
Applicant: ABBOTT MEDICAL
PMA number: P880086
Supplement: S095
Product code: DXY
Generic name: implantable pacemaker Pulse-generator
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.