PMA P910023S073

Device: HOUSECALL PLUS TRANSTELEPHONIC MONITORING SYSTEM WITH MODEL 3180-T TRANSMITTER AND MODEL 3180-R RECEIVER SOFTWARE (VERS
Applicant: ABBOTT MEDICAL
PMA number: P910023
Supplement: S073
Product code: DXY
Decision date: 2004-05-12
Classification: Implantable Pacemaker Pulse-generator
Generic name: implantable pacemaker Pulse-generator
Approval order statement: APPROVAL FOR SOFTWARE MODIFICATIONS TO THE ST. JUDE MEDICAL HOUSECALL PLUS RECEIVER SOFTWARE (VERSION 2.0) WHICH ALSO INCLUDES THE SUPPORT FOR THE ST. JUDE MEDICAL EPIC AND ATLAS ICD FAMILIES.

Current openFDA PMA Record#

Device: HOUSECALL PLUS TRANSTELEPHONIC MONITORING SYSTEM WITH MODEL 3180-T TRANSMITTER AND MODEL 3180-R RECEIVER SOFTWARE (VERS
Applicant: ABBOTT MEDICAL
PMA number: P910023
Supplement: S073
Product code: DXY
Generic name: implantable pacemaker Pulse-generator
Decision date: 2004-05-12
Decision code: APPR
Date received: 2004-04-15
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR SOFTWARE MODIFICATIONS TO THE ST. JUDE MEDICAL HOUSECALL PLUS RECEIVER SOFTWARE (VERSION 2.0) WHICH ALSO INCLUDES THE SUPPORT FOR THE ST. JUDE MEDICAL EPIC AND ATLAS ICD FAMILIES.