PMA P030054S250
- Device
- UNIFY, UNIFY ASSURA, QUADRA ASSURA FAMILY OF CRT-D'S
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S250
- Product code
- NIK
- Decision date
- 2013-06-12
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- MODIFICATION OF AUX CONVERTER ATE TESTING FOR THE DEVICES.
Current openFDA PMA Record#
- Device
- UNIFY, UNIFY ASSURA, QUADRA ASSURA FAMILY OF CRT-D'S
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S250
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2013-06-12
- Decision code
- OK30
- Date received
- 2013-05-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MODIFICATION OF AUX CONVERTER ATE TESTING FOR THE DEVICES.