PMA P030054S224
- Device
- EPIC HF/ATLAS+HF/QUADRA ASSURA/UNIFY ASSURA FAMILY OF CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S224
- Product code
- NIK
- Decision date
- 2012-07-06
- 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 AN UPDATE TO THE MODEL 3330 PROGRAMMER SOFTWARE FROM VERSION 14.1 TO 15.1.
Current openFDA PMA Record#
- Device
- EPIC HF/ATLAS+HF/QUADRA ASSURA/UNIFY ASSURA FAMILY OF CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S224
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2012-07-06
- Decision code
- APPR
- Date received
- 2012-05-30
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR AN UPDATE TO THE MODEL 3330 PROGRAMMER SOFTWARE FROM VERSION 14.1 TO 15.1.