PMA P890003S307
- Device
- MYCARELINK PATIENT MONITOR
- Applicant
- Medtronic, Inc.
- PMA number
- P890003
- Supplement
- S307
- Product code
- OSR
- Decision date
- 2014-05-29
- Classification
- Pacemaker/icd/crt Non-implanted Components
- Generic name
- Pacemaker/icd/crt non-implanted components
- Approval order statement
- APPROVAL FOR MINOR HARDWARE AND FIRMWARE CHANGES TO THE MYCARELINK PATIENT MONITOR MODEL 24955 RF HEAD FOR THE DEVICES.
Current openFDA PMA Record#
- Device
- MYCARELINK PATIENT MONITOR
- Applicant
- Medtronic, Inc.
- PMA number
- P890003
- Supplement
- S307
- Product code
- OSR
- Generic name
- Pacemaker/icd/crt non-implanted components
- Decision date
- 2014-05-29
- Decision code
- APPR
- Date received
- 2014-03-28
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MINOR HARDWARE AND FIRMWARE CHANGES TO THE MYCARELINK PATIENT MONITOR MODEL 24955 RF HEAD FOR THE DEVICES.