PMA P030054S015
- Device
- AFFINITY/INTEGRITY, PHOTON, ATLAS, EPIC & PSA FAMILIES OF DEVICES
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S015
- Product code
- NIK
- Decision date
- 2005-11-15
- 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 3650 MERLIN PATIENT CARE SYSTEM WITH THE MODEL 3330 VERSION 1.1 SOFTWARE, MODEL 3616 WAND EXTENSION CABLE, AND MODEL 3617 ECG INPUT CABLE.
Current openFDA PMA Record#
- Device
- AFFINITY/INTEGRITY, PHOTON, ATLAS, EPIC & PSA FAMILIES OF DEVICES
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S015
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2005-11-15
- Decision code
- APPR
- Date received
- 2005-10-24
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM WITH THE MODEL 3330 VERSION 1.1 SOFTWARE, MODEL 3616 WAND EXTENSION CABLE, AND MODEL 3617 ECG INPUT CABLE.