AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS

FDA premarket approval P880086/S156 · decided 2007-12-12

Approval details

PMA number

P880086

Supplement

S156

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS

Generic name

Pulse generator, permanent, implantable

Applicant

ABBOTT MEDICAL

Date received

2007-10-24

Decision date

2007-12-12

Days to decision

49 days

Decision code

APPR

Product code

NVZ

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

Statement

APPROVAL FOR TWO CORRECTIVE FIXES TO ADDRESS A HARDWARE ISSUED THAT CAN LEAVE THE CRT-D AND ICD SYSTEMS LISTED ABOVE IN A POST-SENSE REFRACTORY STATE. FOR DEVICES THAT ARE ALREADY IMPLANTED AND/OR ALREADY MANUFACTURED, CHANGES WILL BE MADE TO THE PROGRAMMER SOFTWARE. DURING A PATIENT FOLLOW-UP VISIT, THE PROGRAMMER WILL INTERROGATE THE DEVICE AND DOWNLOAD FIRMWARE RAM CODE TO CORRECT THE ANOMALOUS CONDITION IF IT OCCURS. FOR NEW DEVICES, A MODIFICATION HAS BEEN MADE TO THE SIO2 CHIP HARDWARE TO

510(k) clearances by this applicant