MYCARELINK SMART MONITOR AND THE MYCARELINK HEART APPLICATION
FDA premarket approval P890003/S313 · decided 2015-01-26
Approval details
- PMA number
- P890003
- Supplement
- S313
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MYCARELINK SMART MONITOR AND THE MYCARELINK HEART APPLICATION
- Generic name
- Pacemaker/icd/crt non-implanted components
- Applicant
- Medtronic, Inc.
- Date received
- 2014-07-18
- Decision date
- 2015-01-26
- Days to decision
- 192 days
- Decision code
- APPR
- Product code
- OSR
- 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
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