PMA P880086S261
- Device
- ASSURITY, ASSURITY+, ENDURITY, ACCENT FAMILY PACEMAKERS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S261
- Product code
- NVZ
- Decision date
- 2016-05-12
- Classification
- Pulse Generator, Permanent, Implantable
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- Approval for updates to the Merlin@home EX2000 v8.2 Software and the Merlin.net MN5000 v7.4 Software.
Current openFDA PMA Record#
- Device
- ASSURITY, ASSURITY+, ENDURITY, ACCENT FAMILY PACEMAKERS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S261
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2016-05-12
- Decision code
- APPR
- Date received
- 2015-09-15
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for updates to the Merlin@home EX2000 v8.2 Software and the Merlin.net MN5000 v7.4 Software.