AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS

FDA premarket approval P880086/S174 · decided 2009-07-15

Approval details

PMA number

P880086

Supplement

S174

Supplement type

Normal 180 Day Track

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

2009-01-22

Decision date

2009-07-15

Days to decision

174 days

Decision code

APPR

Product code

NVZ

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

Statement

APPROVAL FOR THE ACCENT / ACCENT RF IMPLANTABLE PULSE GENERATORS AND ANTHEM / ANTHEM RF CRT-PS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ACCENT / ACCENT RF IMPLANTABLE PULSE GENERATORS AND ANTHEM / ANTHEM RF CRT-PS. THE DEVICE IS INDICATED FOR: 1) MAINTAINING SYNCHRONY OF THE LEFT AND RIGHT VENTRICLES IN PATIENTS WHO HAVE UNDERGONEAN AV NODAL ABLATION FOR CHRONIC ATRIAL FIBRILLATION AND HAVE NYHA CLASS II OR III HEART FAILURE. 2) THE REDUCTION OF THE SYMPTOMS OF MODERATE TO

510(k) clearances by this applicant