PMA P140033S061
- Device
- Assurity MRI and Endurity MRI
- Applicant
- ABBOTT MEDICAL
- PMA number
- P140033
- Supplement
- S061
- Product code
- LWP
- Decision date
- 2020-10-29
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Alternate supplier of the ceramic capacitor component.
Current openFDA PMA Record#
- Device
- Assurity MRI and Endurity MRI
- Applicant
- ABBOTT MEDICAL
- PMA number
- P140033
- Supplement
- S061
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2020-10-29
- Decision code
- OK30
- Date received
- 2020-09-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate supplier of the ceramic capacitor component.