PMA P030054S198
- Device
- EPIC HF/ATLAS+ HF/PROMOTE FAMILY OF CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S198
- Product code
- LWP
- Decision date
- 2011-09-08
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- APPROVAL FOR MODEL 3330 VERSION 13.1 PROGRAMMER SOFTWARE WHICH INCLUDES ENHANCEMENTS TO THE LAYOUT/DESIGN OF THE EXISTING MERLIN PCS PRINTED REPORTS.
Current openFDA PMA Record#
- Device
- EPIC HF/ATLAS+ HF/PROMOTE FAMILY OF CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S198
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2011-09-08
- Decision code
- APPR
- Date received
- 2011-08-08
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODEL 3330 VERSION 13.1 PROGRAMMER SOFTWARE WHICH INCLUDES ENHANCEMENTS TO THE LAYOUT/DESIGN OF THE EXISTING MERLIN PCS PRINTED REPORTS.