PMA P150035S002
- Device
- Aveir
- Applicant
- ABBOTT MEDICAL
- PMA number
- P150035
- Supplement
- S002
- Product code
- PNJ
- Decision date
- 2022-10-06
- Generic name
- Leadless pacemaker
- Approval order statement
- Add an alternate supplier for the sub-processing of the Wafer Level Chip Scale Package.
Current openFDA PMA Record#
- Device
- Aveir
- Applicant
- ABBOTT MEDICAL
- PMA number
- P150035
- Supplement
- S002
- Product code
- PNJ
- Generic name
- Leadless pacemaker
- Decision date
- 2022-10-06
- Decision code
- OK30
- Date received
- 2022-09-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add an alternate supplier for the sub-processing of the Wafer Level Chip Scale Package.