PMA P880086S258
- Device
- ASSURITY, ASSURITY+, ENDURITY, ACCENT FAMILY OF PACEMAKERS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S258
- Product code
- NVZ
- Decision date
- 2015-09-16
- Classification
- Pulse Generator, Permanent, Implantable
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- APPROVAL FOR UPDATES TO THE MERLIN@HOME EX2000 V8.1.1 SOFTWARE FOR MODELS EX1150, EX1150W, EX1100, AND EX1100W TRANSMITTERS.
Current openFDA PMA Record#
- Device
- ASSURITY, ASSURITY+, ENDURITY, ACCENT FAMILY OF PACEMAKERS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S258
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2015-09-16
- Decision code
- APPR
- Date received
- 2015-07-23
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR UPDATES TO THE MERLIN@HOME EX2000 V8.1.1 SOFTWARE FOR MODELS EX1150, EX1150W, EX1100, AND EX1100W TRANSMITTERS.