PMA P030054S235
- Device
- ATLAS+HF, ATLAS II, HF, ATLAS II+ HF, EPIC + EPIC HF, EPIC + EPIC II HF, EPIC II + HF, PROMOTE, PROMOTE + PROMOTE RF, PR
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S235
- Product code
- NIK
- Decision date
- 2012-10-31
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- ALTERNATE SUPPLIER OF THE SEPTUM COMPONENT.
Current openFDA PMA Record#
- Device
- ATLAS+HF, ATLAS II, HF, ATLAS II+ HF, EPIC + EPIC HF, EPIC + EPIC II HF, EPIC II + HF, PROMOTE, PROMOTE + PROMOTE RF, PR
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S235
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2012-10-31
- Decision code
- OK30
- Date received
- 2012-09-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ALTERNATE SUPPLIER OF THE SEPTUM COMPONENT.