PMA P150035S028
- Device
- AVEIR™ Patient Transmitter (model, LSRM01), AVEIR™ Patient Transmitter Software (model, LSRM1000 v 1.0), AVEIR Patient T
- Applicant
- ABBOTT MEDICAL
- PMA number
- P150035
- Supplement
- S028
- Product code
- OSR
- Decision date
- 2025-09-24
- Classification
- Cardiovascular
- Generic name
- Pacemaker/icd/crt non-implanted components
- Approval order statement
- approval for the AVEIR Remote Care System ECG Feature
Current openFDA PMA Record#
- Device
- AVEIR™ Patient Transmitter (model, LSRM01), AVEIR™ Patient Transmitter Software (model, LSRM1000 v 1.0), AVEIR Patient T
- Applicant
- ABBOTT MEDICAL
- PMA number
- P150035
- Supplement
- S028
- Product code
- OSR
- Generic name
- Pacemaker/icd/crt non-implanted components
- Decision date
- 2025-09-24
- Decision code
- APPR
- Date received
- 2025-06-27
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for the AVEIR Remote Care System ECG Feature