PMA P980016S492
- Device
- 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
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S492
- Product code
- LWS
- Decision date
- 2015-01-26
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order 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 FOR USE:THE MEDTRONIC MYCARELINK HEART APPLICATION TRANSMITS IMPLANTED HEART DEVICE DATA TO THE CARELINK NETWORK VIA A MOBILE DEVICE.
Current openFDA PMA Record#
- Device
- 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
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S492
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2015-01-26
- Decision code
- APPR
- Date received
- 2014-07-18
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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 FOR USE:THE MEDTRONIC MYCARELINK HEART APPLICATION TRANSMITS IMPLANTED HEART DEVICE DATA TO THE CARELINK NETWORK VIA A MOBILE DEVICE.