PMA P890003S344
- Device
- MEDTRONIC CARELINK MONITOR, MYCARELINK PATIENT MONITOR
- Applicant
- Medtronic, Inc.
- PMA number
- P890003
- Supplement
- S344
- Product code
- OSR
- Decision date
- 2016-02-05
- Classification
- Pacemaker/icd/crt Non-implanted Components
- Generic name
- Pacemaker/icd/crt non-implanted components
- Approval order statement
- Approval for the Alert Management Feature for the CareLink Network.
Current openFDA PMA Record#
- Device
- MEDTRONIC CARELINK MONITOR, MYCARELINK PATIENT MONITOR
- Applicant
- Medtronic, Inc.
- PMA number
- P890003
- Supplement
- S344
- Product code
- OSR
- Generic name
- Pacemaker/icd/crt non-implanted components
- Decision date
- 2016-02-05
- Decision code
- APPR
- Date received
- 2015-11-16
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the Alert Management Feature for the CareLink Network.