PMA P030054S088
- Device
- EPIC HF FAMILY CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S088
- Product code
- NIK
- Decision date
- 2008-06-24
- 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 MINOR MODIFICATIONS AND STANDARDIZATION OF THE GROUND CONNECTION, OUTPUT FLEX, HEAT SHIELD, AND BATTERY SUPPORT FOR ATLA, ATLAS II, CONVERT, CURRENT, EPIC, EPIC II, AND PROMOTE CRT-D AND ICD FAMILIES.
Current openFDA PMA Record#
- Device
- EPIC HF FAMILY CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S088
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2008-06-24
- Decision code
- APPR
- Date received
- 2008-05-09
- Supplement type
- Real-Time Process
- Approval order statement
- APPROVAL FOR MINOR MODIFICATIONS AND STANDARDIZATION OF THE GROUND CONNECTION, OUTPUT FLEX, HEAT SHIELD, AND BATTERY SUPPORT FOR ATLA, ATLAS II, CONVERT, CURRENT, EPIC, EPIC II, AND PROMOTE CRT-D AND ICD FAMILIES.