PMA P140033S048
- Device
- Assurity MRI, Endurity MRI family of Pacemakers
- Applicant
- ABBOTT MEDICAL
- Product code
- LWP
- Decision date
- 2020-05-13
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Approval for a design and supplier change of the moisture getter.
Current openFDA PMA Record#
- Device
- Assurity MRI, Endurity MRI family of Pacemakers
- Applicant
- ABBOTT MEDICAL
- PMA number
- P140033
- Supplement
- S048
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2020-05-13
- Decision code
- APPR
- Date received
- 2019-10-22
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a design and supplier change of the moisture getter.