PMA P140033S073
- Device
- Assurity MRI, Endurity MRI, and Zenus MRI
- Applicant
- ABBOTT MEDICAL
- PMA number
- P140033
- Supplement
- S073
- Product code
- LWP
- Decision date
- 2022-07-14
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Second-tier supplier's manufacturing site transfer.
Current openFDA PMA Record#
- Device
- Assurity MRI, Endurity MRI, and Zenus MRI
- Applicant
- ABBOTT MEDICAL
- PMA number
- P140033
- Supplement
- S073
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2022-07-14
- Decision code
- OK30
- Date received
- 2022-07-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Second-tier supplier's manufacturing site transfer.