PMA P150035S032
- Device
- AVEIR™ Leadless Pacemaker Real-time Clock (RTC) electrical test
- Applicant
- ABBOTT MEDICAL
- PMA number
- P150035
- Supplement
- S032
- Product code
- PNJ
- Decision date
- 2025-09-30
- Classification
- Cardiovascular
- Generic name
- Leadless pacemaker
- Approval order statement
- update to the current AVEIR™ Leadless Pacemaker Real-time Clock (RTC) electrical test
Current openFDA PMA Record#
- Device
- AVEIR™ Leadless Pacemaker Real-time Clock (RTC) electrical test
- Applicant
- ABBOTT MEDICAL
- PMA number
- P150035
- Supplement
- S032
- Product code
- PNJ
- Generic name
- Leadless pacemaker
- Decision date
- 2025-09-30
- Decision code
- OK30
- Date received
- 2025-08-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- update to the current AVEIR™ Leadless Pacemaker Real-time Clock (RTC) electrical test