PMA P030054S133
- Device
- EPIC HF CRT-D SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S133
- Product code
- NIK
- Decision date
- 2009-11-13
- 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 AN ALTERNATE SUPPLIER AND ASSOCIATED DESIGN CHANGES FOR THE ANTENNA PRINTED CIRCUIT BOARD (PCB) FOR THE MERLIN@HOME MODEL EX1150 TRANSMITTER.
Current openFDA PMA Record#
- Device
- EPIC HF CRT-D SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S133
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2009-11-13
- Decision code
- APPR
- Date received
- 2009-09-01
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR AN ALTERNATE SUPPLIER AND ASSOCIATED DESIGN CHANGES FOR THE ANTENNA PRINTED CIRCUIT BOARD (PCB) FOR THE MERLIN@HOME MODEL EX1150 TRANSMITTER.