PMA P140033S067
- Device
- Assurity MRI, Endurity MRI family of Pacemakers
- Applicant
- ABBOTT MEDICAL
- PMA number
- P140033
- Supplement
- S067
- Product code
- LWP
- Decision date
- 2021-06-28
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Approval for changes to the Merlin PCS 3650 Programmer Model 3330 Software to create v25.1.1.
Current openFDA PMA Record#
- Device
- Assurity MRI, Endurity MRI family of Pacemakers
- Applicant
- ABBOTT MEDICAL
- PMA number
- P140033
- Supplement
- S067
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2021-06-28
- Decision code
- APPR
- Date received
- 2021-04-02
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for changes to the Merlin PCS 3650 Programmer Model 3330 Software to create v25.1.1.