PMA P030054S024
- Device
- EPIC HF & ATLAS HF CRT-D'S MODEL 3650 MERLIN PATIENT CARE SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S024
- Product code
- NIK
- Decision date
- 2006-04-05
- 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 MODEL 3330 VERSION 3.0 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM WHICH ADDS THE SUPPORT FOR THE USE OF MERLIN WITH THE VICTORY, EPIC II AND FRONTIER II PULSE GENERATOR FAMILIES.
Current openFDA PMA Record#
- Device
- EPIC HF & ATLAS HF CRT-D'S MODEL 3650 MERLIN PATIENT CARE SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S024
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2006-04-05
- Decision code
- APPR
- Date received
- 2006-03-07
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE MODEL 3330 VERSION 3.0 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM WHICH ADDS THE SUPPORT FOR THE USE OF MERLIN WITH THE VICTORY, EPIC II AND FRONTIER II PULSE GENERATOR FAMILIES.