PMA P030054S003
- Device
- EPIC HF CRT-D
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S003
- Product code
- NIK
- Decision date
- 2004-10-25
- 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 MODIFICATIONS TO THE DESIGN OF THE FEEDTHROUGH ASSEMBLY OF THE EPIC HF DEVICE MODEL V-338 AND MINOR MODIFICATIONS TO PROVIDE CONSISTENCY IN THE MANUFACTURING PROCESS OF EPIC HF AND EPIC DR/VR ICDS.
Current openFDA PMA Record#
- Device
- EPIC HF CRT-D
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S003
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2004-10-25
- Decision code
- APPR
- Date received
- 2004-09-27
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE DESIGN OF THE FEEDTHROUGH ASSEMBLY OF THE EPIC HF DEVICE MODEL V-338 AND MINOR MODIFICATIONS TO PROVIDE CONSISTENCY IN THE MANUFACTURING PROCESS OF EPIC HF AND EPIC DR/VR ICDS.