PMA P030054S023
- Device
- EPIC II/ EPIC II IMPLANTABLE CARDIOVERTERS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S023
- Product code
- NIK
- Decision date
- 2006-07-28
- 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 MODIFICATIONS TO THE PROGRAMMER SOFTWARE, MODEL 3307 V6.1.1C AND MODEL 3330 V4.1.1, TO INCLUDE THE QUICKOPT TIMING CYCLE FEATURE.
Current openFDA PMA Record#
- Device
- EPIC II/ EPIC II IMPLANTABLE CARDIOVERTERS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S023
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2006-07-28
- Decision code
- APPR
- Date received
- 2006-02-17
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE MODIFICATIONS TO THE PROGRAMMER SOFTWARE, MODEL 3307 V6.1.1C AND MODEL 3330 V4.1.1, TO INCLUDE THE QUICKOPT TIMING CYCLE FEATURE.