PMA P150035
- Device
- AVEIR Patient Transmitter LSRM01
- Applicant
- ABBOTT MEDICAL
- PMA number
- P150035
- Supplement
- S002
- Product code
- PNJ
- Decision date
- 2026-06-17
- Generic name
- Leadless pacemaker
- Approval order statement
- to automate a visual inspection step during the manufacturing of the Aveir Patient Transmitter
Current openFDA PMA Record#
- Device
- AVEIR Patient Transmitter LSRM01
- Applicant
- ABBOTT MEDICAL
- PMA number
- P150035
- Supplement
- S040
- Product code
- PNJ
- Generic name
- Leadless pacemaker
- Decision date
- 2026-06-17
- Decision code
- OK30
- Date received
- 2026-05-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to automate a visual inspection step during the manufacturing of the Aveir Patient Transmitter