PMA P030054S049
- Device
- QUICKFLEX MODEL 1156T AND XL MODEL 1158T LEFT VENTRICULAR PACING LEADS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S049
- Product code
- NIK
- Decision date
- 2007-07-25
- 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 DISTAL TIP MODIFICATIONS TO THE QUICKSITE LEAD FAMILY TO REDUCE THE LENGTH OF RIGID SECTIONS AND INCREASE LEAD FLEXIBILITY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME QUICKFLEX MODEL 1156T AND XL MODEL 1158T LEFT VENTRICULAR PACING LEADS. QUICKFLEX LEADS ARE 6 FRENCH, TRANSVENOUS, STEROID ELUTING, BIPOLAR, IS-1 COMPATIBLE, S-SHAPED CURVE, PASSIVE FIXATION LEADS INTENDED FOR PERMANENT SENSING AND PACING OF THE LEFT VENTRICLE WHEN USED WITH A COMPATIBLE ST. JUDE MEDICAL?S BIVENTRICULAR SYSTEM.
Current openFDA PMA Record#
- Device
- QUICKFLEX MODEL 1156T AND XL MODEL 1158T LEFT VENTRICULAR PACING LEADS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S049
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2007-07-25
- Decision code
- APPR
- Date received
- 2007-02-05
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR DISTAL TIP MODIFICATIONS TO THE QUICKSITE LEAD FAMILY TO REDUCE THE LENGTH OF RIGID SECTIONS AND INCREASE LEAD FLEXIBILITY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME QUICKFLEX MODEL 1156T AND XL MODEL 1158T LEFT VENTRICULAR PACING LEADS. QUICKFLEX LEADS ARE 6 FRENCH, TRANSVENOUS, STEROID ELUTING, BIPOLAR, IS-1 COMPATIBLE, S-SHAPED CURVE, PASSIVE FIXATION LEADS INTENDED FOR PERMANENT SENSING AND PACING OF THE LEFT VENTRICLE WHEN USED WITH A COMPATIBLE ST. JUDE MEDICAL?S BIVENTRICULAR SYSTEM.