PMA P030054S237
- Device
- MERLIN NET 6.1M
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S237
- Product code
- NIK
- Decision date
- 2012-12-19
- 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 EX2000 SOFTWARE VERSION 6.1 M FOR MARLIN@HOME WITHOUT THE CELLULAR ADAPTER.
Current openFDA PMA Record#
- Device
- MERLIN NET 6.1M
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S237
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2012-12-19
- Decision code
- APPR
- Date received
- 2012-10-15
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE EX2000 SOFTWARE VERSION 6.1 M FOR MARLIN@HOME WITHOUT THE CELLULAR ADAPTER.