PMA P030054S060
- Device
- EPIC HF CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S060
- Product code
- NIK
- Decision date
- 2007-08-17
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- ALTERNATE SUPPLIER FOR THE ISOLATION TRANSFORMER MODULE (ITM) AND TOROID INDUCTOR USED ON THE HIGH VOLTAGE HYBRID ASSEMBLY OF THE CURRENT ICDS AND PROMOTE CRT-DS.
Current openFDA PMA Record#
- Device
- EPIC HF CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S060
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2007-08-17
- Decision code
- OK30
- Date received
- 2007-07-19
- Supplement type
- 30-Day Notice
- Approval order statement
- ALTERNATE SUPPLIER FOR THE ISOLATION TRANSFORMER MODULE (ITM) AND TOROID INDUCTOR USED ON THE HIGH VOLTAGE HYBRID ASSEMBLY OF THE CURRENT ICDS AND PROMOTE CRT-DS.