PMA P030054S232
- Device
- QUARTET IS4 LEAD MODELS 1458Q
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S232
- Product code
- NIK
- Decision date
- 2012-10-16
- 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 CHANGES TO THE PACKAGING OF THE QUARTET IS4 AND DURATA DF4 LEADS.
Current openFDA PMA Record#
- Device
- QUARTET IS4 LEAD MODELS 1458Q
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S232
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2012-10-16
- Decision code
- APPR
- Date received
- 2012-09-05
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR CHANGES TO THE PACKAGING OF THE QUARTET IS4 AND DURATA DF4 LEADS.