PMA P030054S261
- Device
- PROMOTE, QUADRA ASSURA, UNIFY, UNIFY ASSURA, UNIFY QUADRA FAMILIES OF CRT-D DEVICES
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S261
- Product code
- NIK
- Decision date
- 2014-03-04
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- CHANGE IN THE WIRE BOND PROCESS VERIFICATION FREQUENCY UTILIZED FOR THE HYBRID ASSEMBLIES OF THE DEVICES.
Current openFDA PMA Record#
- Device
- PROMOTE, QUADRA ASSURA, UNIFY, UNIFY ASSURA, UNIFY QUADRA FAMILIES OF CRT-D DEVICES
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S261
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2014-03-04
- Decision code
- OK30
- Date received
- 2014-02-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE WIRE BOND PROCESS VERIFICATION FREQUENCY UTILIZED FOR THE HYBRID ASSEMBLIES OF THE DEVICES.