PMA P030054S131
- Device
- EPIC HF CRT-D SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S131
- Product code
- NIK
- Decision date
- 2010-01-29
- 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 CURRENT ACCEL ICD MODELS CD2215/CD1215 AND PROMOTE ACCEL CRT-D MODEL CD3215 PULSE GENERATORS AND THE MODEL 3330 VERSION 7.1.2.1.
Current openFDA PMA Record#
- Device
- EPIC HF CRT-D SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S131
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2010-01-29
- Decision code
- APPR
- Date received
- 2009-08-04
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE CURRENT ACCEL ICD MODELS CD2215/CD1215 AND PROMOTE ACCEL CRT-D MODEL CD3215 PULSE GENERATORS AND THE MODEL 3330 VERSION 7.1.2.1.