EASYTRAK 3 CORONARY VENOUS STERIOD ELUTING BIPOLAR PACE/SENSE LEAD
FDA premarket approval P010012/S025 · decided 2004-08-06
Approval details
- PMA number
- P010012
- Supplement
- S025
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EASYTRAK 3 CORONARY VENOUS STERIOD ELUTING BIPOLAR PACE/SENSE LEAD
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Boston Scientific Corp
- Date received
- 2004-03-10
- Decision date
- 2004-08-06
- Days to decision
- 149 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR CHANGES IN FIXATION DESIGN, LEAD LENGTHS AND ENABLING BIPOLAR PACE/SENSE CAPABILITY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EASYTRAK 3 AND IS INDICATED FOR CHRONIC, LEFT VENTRICULAR PACING AND SENSING VIA THE CORONARY VEINS, WHEN USED IN CONJUNCTION WITH A COMPATIBLE GUIDANT CARDIAC RESYNCHRONIZATION THERAPY (CRT) DEVICE.
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