PMA P880086S237

Device: AFFINITY/ INTEGRITY/ VICTORY/ ZEPHYR/ACCENT FAMILY OF PACEMAKERS
Applicant: ABBOTT MEDICAL
PMA number: P880086
Supplement: S237
Product code: NVZ
Decision date: 2014-02-26
Classification: Pulse Generator, Permanent, Implantable
Generic name: Pulse generator, permanent, implantable
Approval order statement: APPROVAL FOR THE FOLLOWING SOFTWARE PACKAGES TO BE USED WITH THE DEVICES. THOSE SOFTWARE PACKAGES ARE:MODEL 3330 VERSION 18.1 SOFTWARE FOR THE MODEL 3650 PATIENT CARE SYSTEM (PCS) PROGRAMMER; MODEL EX2000 VERSION 7.0 REV. 1 SOFTWARE FOR MODELS EX1100 AND EX1150 MERLIN@HOME TRANSMITTERS; ANDMODEL MN5000 VERSION 7.1 SOFTWARE FOR THE MERLIN.NET SYSTEM.

Current openFDA PMA Record#

Device: AFFINITY/ INTEGRITY/ VICTORY/ ZEPHYR/ACCENT FAMILY OF PACEMAKERS
Applicant: ABBOTT MEDICAL
PMA number: P880086
Supplement: S237
Product code: NVZ
Generic name: Pulse generator, permanent, implantable
Decision date: 2014-02-26
Decision code: APPR
Date received: 2013-11-21
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE FOLLOWING SOFTWARE PACKAGES TO BE USED WITH THE DEVICES. THOSE SOFTWARE PACKAGES ARE:MODEL 3330 VERSION 18.1 SOFTWARE FOR THE MODEL 3650 PATIENT CARE SYSTEM (PCS) PROGRAMMER; MODEL EX2000 VERSION 7.0 REV. 1 SOFTWARE FOR MODELS EX1100 AND EX1150 MERLIN@HOME TRANSMITTERS; ANDMODEL MN5000 VERSION 7.1 SOFTWARE FOR THE MERLIN.NET SYSTEM.