PMA P030054S141
- Device
- UNIFY CRT-D SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S141
- Product code
- NIK
- Decision date
- 2010-05-07
- 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 THE UNIFY CRT-D PULSE GENERATORS.
Current openFDA PMA Record#
- Device
- UNIFY CRT-D SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S141
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2010-05-07
- Decision code
- APPR
- Date received
- 2009-11-05
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE UNIFY CRT-D PULSE GENERATORS.