PMA P030054S119
- Device
- EPIC HF / ATLAS + HF FAMILY OF CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S119
- Product code
- NIK
- Decision date
- 2009-04-14
- 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 MODIFICATIONS TO THE HIGH VOLTAGE CAPACITORS FOR ATLAS, +/II, CURRENT AND PROMOTE, RF/+ HE (36 J) AND EPIC, +/II CURRENT AND PROMOTE, RF/+ SE (30 J) FAMILIES OF ICD/CRT-D DEVICES.
Current openFDA PMA Record#
- Device
- EPIC HF / ATLAS + HF FAMILY OF CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S119
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2009-04-14
- Decision code
- APPR
- Date received
- 2009-03-04
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE HIGH VOLTAGE CAPACITORS FOR ATLAS, +/II, CURRENT AND PROMOTE, RF/+ HE (36 J) AND EPIC, +/II CURRENT AND PROMOTE, RF/+ SE (30 J) FAMILIES OF ICD/CRT-D DEVICES.