EVERA S DR/S VR,XT DR, XT VR ICD; ENTRUST; INTRINSIC 30 & INTRINSIC ICD; MARQUIS DR, VR ICD; MAXIMO DR, II, VR ICD; PROT

FDA premarket approval P980016/S492 · decided 2015-01-26

Approval details

PMA number

P980016

Supplement

S492

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

EVERA S DR/S VR,XT DR, XT VR ICD; ENTRUST; INTRINSIC 30 & INTRINSIC ICD; MARQUIS DR, VR ICD; MAXIMO DR, II, VR ICD; PROT

Generic name

Implantable cardioverter defibrillator (non-CRT)

Applicant

Medtronic Cardiac Rhythm Disease Management

Date received

2014-07-18

Decision date

2015-01-26

Days to decision

192 days

Decision code

APPR

Product code

LWS

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

Statement

APPROVAL FOR THE MYCARELINK SMART MONITOR USED WITH THE DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MYCARELINK SMART MONITOR ANDTHE MYCARELINK HEART APPLICATION AND IS INDICATED FOR:PATIENT READER INDICATIONS FOR USE:THE PATIENT READER IS A PORTABLE ELECTRONIC DEVICE THAT COMMUNICATES WITH YOUR MEDTRONICIMPLANTED HEART DEVICE. THE APPLICATION ON SMART PHONE OR TABLET TRANSMITS IMPLANTED HEARTDEVICE DATA TO THE MEDTRONIC CARELINK NETWORK. MOBILE APPLICATION INDICATIONS