MICRONY PACEMAKERS

FDA premarket approval P970013/S004 · decided 2006-03-14

Approval details

PMA number

P970013

Supplement

S004

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

MICRONY PACEMAKERS

Generic name

Pulse-generator, single chamber, sensor driven, implantable

Applicant

ABBOTT MEDICAL

Date received

2006-01-25

Decision date

2006-03-14

Days to decision

48 days

Decision code

APPR

Product code

LWO

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

Statement

APPROVAL FOR MODIFICATIONS TO THE EPIC II/EPIC II+ AND EPIC II HF DEVICES. THE MODIFICATIONS INCLUDE ADDING A VIBRATORY PATIENT NOTIFIER; MODIFYING THE ELECTROGRAM MORPHOLOGY ALGORITHM; MODIFYING THE CAPACITOR MAINTENANCE FEATURE; CHANGING THE MATERIALS OF THE CAN AND HEADER; AND MINOR CHANGES TO PACKAGING AND SOFTWARE. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES EPIC II/EPIC II+ DR/VR/HF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS (MODELS V-158, V-255, V-258, AND V-355)

510(k) clearances by this applicant