PMA P030054S018
- Device
- QUICKSITE XL MODEL 1058T LEFT VENTRICULAR PACING LEAD
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S018
- Product code
- NIK
- Decision date
- 2006-02-15
- 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 A MODIFICATION TO THE QUICKSITE XL MODEL 1058T LEFT VENTRICULAR PACING LEAD TO INCREASE THE PEAK-TO-PEAK AMPLITUDE OF THEN DISTAL S-CURVE HEIGHT TO 16 MM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME QUICKSITE XL MODEL 1058T LEFT VENTRICULAR PACING LEAD AND IS INDICATED FOR APPLICATION AS PART OF A ST. JUDE MEDICAL BIVENTRICULAR SYSTEM.
Current openFDA PMA Record#
- Device
- QUICKSITE XL MODEL 1058T LEFT VENTRICULAR PACING LEAD
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S018
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2006-02-15
- Decision code
- APPR
- Date received
- 2005-11-07
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A MODIFICATION TO THE QUICKSITE XL MODEL 1058T LEFT VENTRICULAR PACING LEAD TO INCREASE THE PEAK-TO-PEAK AMPLITUDE OF THEN DISTAL S-CURVE HEIGHT TO 16 MM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME QUICKSITE XL MODEL 1058T LEFT VENTRICULAR PACING LEAD AND IS INDICATED FOR APPLICATION AS PART OF A ST. JUDE MEDICAL BIVENTRICULAR SYSTEM.