PMA P880086S260

Device: AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS
Applicant: ABBOTT MEDICAL
PMA number: P880086
Supplement: S260
Product code: NVZ
Decision date: 2016-02-12
Classification: Pulse Generator, Permanent, Implantable
Generic name: Pulse generator, permanent, implantable
Approval order statement: Approval for Quadra Assura MP Cardiac Resynchronization Therapy devices (CRT-Ds) Models CD3269-40, CD3269-40Q, CD3369-40, CD3369-40Q, CD3369-40C, CD3369- 40QC; Quadra Allure MP Cardiac Resynchronization Therapy Pacemaker devices (CRT-Ps) Models PM3160 and PM3262; and Model 3330 Version 21.1 Software for the Model 3650 Merlin Patient Care System Programmer.

Current openFDA PMA Record#

Device: AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS
Applicant: ABBOTT MEDICAL
PMA number: P880086
Supplement: S260
Product code: NVZ
Generic name: Pulse generator, permanent, implantable
Decision date: 2016-02-12
Decision code: APPR
Date received: 2015-08-17
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for Quadra Assura MP Cardiac Resynchronization Therapy devices (CRT-Ds) Models CD3269-40, CD3269-40Q, CD3369-40, CD3369-40Q, CD3369-40C, CD3369- 40QC; Quadra Allure MP Cardiac Resynchronization Therapy Pacemaker devices (CRT-Ps) Models PM3160 and PM3262; and Model 3330 Version 21.1 Software for the Model 3650 Merlin Patient Care System Programmer.