PMA P890003S368
- Device
- MYCARELINK PATIENT MONITOR MODEL
- Applicant
- Medtronic, Inc.
- PMA number
- P890003
- Supplement
- S368
- Product code
- OSR
- Decision date
- 2017-06-09
- Classification
- Pacemaker/icd/crt Non-implanted Components
- Generic name
- Pacemaker/icd/crt non-implanted components
- Approval order statement
- Approval for hardware, firmware, labeling, and manufacturing changes to support replacing the Bluetooth (BT) Classic module with a BT Low Energy module in the monitor base station.
Current openFDA PMA Record#
- Device
- MYCARELINK PATIENT MONITOR MODEL
- Applicant
- Medtronic, Inc.
- PMA number
- P890003
- Supplement
- S368
- Product code
- OSR
- Generic name
- Pacemaker/icd/crt non-implanted components
- Decision date
- 2017-06-09
- Decision code
- APPR
- Date received
- 2016-11-16
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for hardware, firmware, labeling, and manufacturing changes to support replacing the Bluetooth (BT) Classic module with a BT Low Energy module in the monitor base station.