PMA P030054S100
- Device
- EPIC HF CRT-D SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S100
- Product code
- NIK
- Decision date
- 2008-08-19
- 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 QUICKSTART GUIDE (LABLEING FOR THE MERLIN@HOME DM EX1150 TRANSMITTER).
Current openFDA PMA Record#
- Device
- EPIC HF CRT-D SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S100
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2008-08-19
- Decision code
- APPR
- Date received
- 2008-08-11
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE QUICKSTART GUIDE (LABLEING FOR THE MERLIN@HOME DM EX1150 TRANSMITTER).