PMA P880086S249
- Device
- AFFINITY/INTEGRITY/VICTORY/ZEPHR/ACCENT FAMILY OF PACEMAKERS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S249
- Product code
- LWP
- Decision date
- 2014-12-11
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- APPROVAL FOR MODEL EX2000 V8.0 SOFTWARE FOR THE MODELS EX1100AND EX1150 MERLIN@HOME TRANSMITTERS USED WITH THE DEVICES.
Current openFDA PMA Record#
- Device
- AFFINITY/INTEGRITY/VICTORY/ZEPHR/ACCENT FAMILY OF PACEMAKERS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S249
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2014-12-11
- Decision code
- APPR
- Date received
- 2014-10-20
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODEL EX2000 V8.0 SOFTWARE FOR THE MODELS EX1100AND EX1150 MERLIN@HOME TRANSMITTERS USED WITH THE DEVICES.