PMA P030054S275
- Device
- PROMOTE, PROMOTE ACCEL, PROMOTE Q, PROMOTE QUARDA, PROMOTE RF PROMOTE+ QUADRA ASSURA, UNIFY, ASSURA, UNIFY QUADRA FAMILI
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S275
- Product code
- NIK
- Decision date
- 2014-10-21
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- ALTERNATE SUPPLIER FOR THE HIGH VOLTAGE (HV) RF MODULES UTILIZED IN THE DEVICES ONLY.
Current openFDA PMA Record#
- Device
- PROMOTE, PROMOTE ACCEL, PROMOTE Q, PROMOTE QUARDA, PROMOTE RF PROMOTE+ QUADRA ASSURA, UNIFY, ASSURA, UNIFY QUADRA FAMILI
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S275
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2014-10-21
- Decision code
- OK30
- Date received
- 2014-09-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ALTERNATE SUPPLIER FOR THE HIGH VOLTAGE (HV) RF MODULES UTILIZED IN THE DEVICES ONLY.