PMA P030054S332
- Device
- High Voltage Active Fixation Lead,
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S332
- Product code
- NIK
- Decision date
- 2017-12-19
- 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 MR Conditional labeling for Fortify Assura ICDs, Quadra Assura and Quadra Assura MP CRT-Ds, and Durata, Optisure, Tendril MRI and Quartet lead systems.
Current openFDA PMA Record#
- Device
- High Voltage Active Fixation Lead,
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S332
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2017-12-19
- Decision code
- APPR
- Date received
- 2017-07-03
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for MR Conditional labeling for Fortify Assura ICDs, Quadra Assura and Quadra Assura MP CRT-Ds, and Durata, Optisure, Tendril MRI and Quartet lead systems.