MICRONY FAMILY PACEMAKERS

FDA premarket approval P970013/S054 · decided 2013-06-06

Approval details

PMA number

P970013

Supplement

S054

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

MICRONY FAMILY PACEMAKERS

Generic name

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

Applicant

ABBOTT MEDICAL

Date received

2012-11-14

Decision date

2013-06-06

Days to decision

204 days

Decision code

APPR

Product code

NIK

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

Statement

PPROVAL FOR THE FOLLOWING NEW ELLIPSE/QUADRA ASSURA/FORTIFY ASSURA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) MODELS:1) ELLIPSE VR ICD (CD1411-36, CD1411-36Q, CD1411-36C, CD1411-36QC); 2) FORTIFY ASSURA VR ICD (CD1357-40, CD1357-40Q, CD1357-40C, CD1357-40QC);3) ELLIPSE DR ICD (CD2411-36, CD2411-36Q, CD2411-36C, CD2411-36QC);4) FORTIFY ASSURA DR ICD (CD2357-40, CD2357-40Q, CD2357-40C, CD2357-40QC);5) UNIFY ASSURA CRT-D (CD3357-40, CD33

510(k) clearances by this applicant