CONSULTA CRT-P, SYNERA CRT-P

FDA premarket approval P010015/S244 · decided 2015-01-26

Approval details

PMA number

P010015

Supplement

S244

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

CONSULTA CRT-P, SYNERA CRT-P

Generic name

Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)

Applicant

Medtronic, Inc.

Date received

2014-07-18

Decision date

2015-01-26

Days to decision

192 days

Decision code

APPR

Product code

NKE

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 AND THE MYCARELINK HEART APPLICATION AND IS INDICATED FOR:PATIENT READER INDICATIONS FOR USE: THE PATIENT READER IS A PORTABLE ELECTRONIC DEVICE THAT COMMUNICATES WITH YOUR MEDTRONIC IMPLANTED HEART DEVICE. THE APPLICATION ON SMART PHONE OR TABLET TRANSMITS IMPLANTED HEARTDEVICE DATA TO THE MEDTRONIC CARELINK NETWORK. MOBILE APPLICATION INDICATIO

510(k) clearances by this applicant