PMA P030054S359
- Device
- QuickFlex u 1258T LV Lead
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S359
- Product code
- NIK
- Decision date
- 2018-10-09
- 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 labeling updates to the clinical study summary for the post approval study.
Current openFDA PMA Record#
- Device
- QuickFlex u 1258T LV Lead
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S359
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2018-10-09
- Decision code
- APPR
- Date received
- 2018-07-25
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for labeling updates to the clinical study summary for the post approval study.