PMA P030054S226
- Device
- EPIC HF/ATLAS + HF/QUANDRA ASSURA/UNIFY ASSURA FAMILY OF CRT-D'S
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S226
- Product code
- NIK
- Decision date
- 2014-04-10
- 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 MERLIN CONDUCT MOBILE SOFTWARE APPLICATION AND MODEL 3330 VERSION 16.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM FOR THE DEVICES.
Current openFDA PMA Record#
- Device
- EPIC HF/ATLAS + HF/QUANDRA ASSURA/UNIFY ASSURA FAMILY OF CRT-D'S
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S226
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2014-04-10
- Decision code
- APPR
- Date received
- 2012-07-11
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE MERLIN CONDUCT MOBILE SOFTWARE APPLICATION AND MODEL 3330 VERSION 16.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM FOR THE DEVICES.