PMA P030054S157
- Device
- UNIFY CRT-D
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S157
- Product code
- NIK
- Decision date
- 2010-09-23
- 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 CHANGES TO THE LABELING TO INCLUDE LONGEVITY INFORMATION BASED ON ADDITIONAL BENCH TESTING.
Current openFDA PMA Record#
- Device
- UNIFY CRT-D
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S157
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2010-09-23
- Decision code
- APPR
- Date received
- 2010-07-22
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR CHANGES TO THE LABELING TO INCLUDE LONGEVITY INFORMATION BASED ON ADDITIONAL BENCH TESTING.