PMA P030054S093
- Device
- EPIC HF CRT-D SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S093
- Product code
- NIK
- Decision date
- 2008-07-09
- 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 MERLIN@HOME TRANSMITTER MODEL EX1200, WHICH REPLACE THE LCD TOUCH SCREEN WITH A MEMBRANE PANEL AND CONSOLIDATE INTERNAL CIRCUITRY. THE DEVICE, AS MODIFIED, WILL BE MARKETED AS MODEL EX1150.
Current openFDA PMA Record#
- Device
- EPIC HF CRT-D SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S093
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2008-07-09
- Decision code
- APPR
- Date received
- 2008-05-30
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE MERLIN@HOME TRANSMITTER MODEL EX1200, WHICH REPLACE THE LCD TOUCH SCREEN WITH A MEMBRANE PANEL AND CONSOLIDATE INTERNAL CIRCUITRY. THE DEVICE, AS MODIFIED, WILL BE MARKETED AS MODEL EX1150.