PMA P030054S063
- Device
- EPIC HF CRT-D'S
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S063
- Product code
- NIK
- Decision date
- 2008-03-17
- 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 MERLIN@HOME DM EX 1200 TRANSMITTER WITH SOFTWARE EX 2000.
Current openFDA PMA Record#
- Device
- EPIC HF CRT-D'S
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S063
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2008-03-17
- Decision code
- APPR
- Date received
- 2007-08-13
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MERLIN@HOME DM EX 1200 TRANSMITTER WITH SOFTWARE EX 2000.