PMA P030054S118
- Device
- EPIC HF/ATLAS+HF FAMILY OF CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S118
- Product code
- NIK
- Decision date
- 2009-03-23
- 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 THE MODIFICATIONS OF THE C64 IC (VERSION P) FOR THE EPIC II / ATLAS II PLATFORM OF ICDS, AND SIO2 IC (VERSION G) FOR THE EPIC+ / ATLAS+ AND EPIC II / ATLAS II PLATFORM OF ICDS.
Current openFDA PMA Record#
- Device
- EPIC HF/ATLAS+HF FAMILY OF CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S118
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2009-03-23
- Decision code
- APPR
- Date received
- 2009-02-17
- Supplement type
- Real-Time Process
- Approval order statement
- APPROVAL FOR THE MODIFICATIONS OF THE C64 IC (VERSION P) FOR THE EPIC II / ATLAS II PLATFORM OF ICDS, AND SIO2 IC (VERSION G) FOR THE EPIC+ / ATLAS+ AND EPIC II / ATLAS II PLATFORM OF ICDS.