PMA P030054S188
- Device
- ATLAS +HF, EPIC HF/+HF, PROMOTE RF/+/ACCEL, UNIFY CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S188
- Product code
- NIK
- Decision date
- 2012-12-04
- 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 A MATERIAL CHANGE FROM MEDICAL GRADE POLYSULFONE TO BIOGRADE POLYSULFONE.
Current openFDA PMA Record#
- Device
- ATLAS +HF, EPIC HF/+HF, PROMOTE RF/+/ACCEL, UNIFY CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S188
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2012-12-04
- Decision code
- APPR
- Date received
- 2011-04-19
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A MATERIAL CHANGE FROM MEDICAL GRADE POLYSULFONE TO BIOGRADE POLYSULFONE.