ATLAS HF,ATLAS II HF,ATLAS II,HF,EPIC,EPIC HF,EPIC,EPIC II HF,EPIC II HF,PROMOTE,PROMOTE,PROMOTE RF,PROMOTE ACCEL,UNIFY

FDA premarket approval P030054/S231 · decided 2012-09-24

Approval details

PMA number

P030054

Supplement

S231

Supplement type

30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

ATLAS HF,ATLAS II HF,ATLAS II,HF,EPIC,EPIC HF,EPIC,EPIC II HF,EPIC II HF,PROMOTE,PROMOTE,PROMOTE RF,PROMOTE ACCEL,UNIFY

Generic name

Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

Applicant

ABBOTT MEDICAL

Date received

2012-08-27

Decision date

2012-09-24

Days to decision

28 days

Decision code

OK30

Product code

NIK

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

Statement

REDUCTION IN THE CURE TIME FOR THE ROOM TEMPERATURE VULCANIZED ADHESIVE.

510(k) clearances by this applicant