PMA P030054S070
- Device
- EPIC HF/ATLAS+ FAMILY OF CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S070
- Product code
- NIK
- Decision date
- 2007-11-06
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- APPROVAL FOR MODEL 3330 VERSION 6.3.1 SOFTWARE FOR MODEL 3650 MERLIN PATIENT CARE SYSTEM.
Current openFDA PMA Record#
- Device
- EPIC HF/ATLAS+ FAMILY OF CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S070
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2007-11-06
- Decision code
- APPR
- Date received
- 2007-09-21
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODEL 3330 VERSION 6.3.1 SOFTWARE FOR MODEL 3650 MERLIN PATIENT CARE SYSTEM.