EASYTRAK LEAD MODELS 4510, 4511, 4512 AND 4513 CORONARY VENOUS STEROID ELUTING SINGLE-ELECTRODE PACE/SENSE LEADS
FDA premarket approval P010012/S003 · decided 2003-01-22
Approval details
- PMA number
- P010012
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EASYTRAK LEAD MODELS 4510, 4511, 4512 AND 4513 CORONARY VENOUS STEROID ELUTING SINGLE-ELECTRODE PACE/SENSE LEADS
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Boston Scientific Corp
- Date received
- 2002-07-26
- Decision date
- 2003-01-22
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR ADDING A POLYURETHANE SLEEVE OVER THE SILICONE INSULATION IN THE TERMINAL CONNECTOR AREA AND MINOR CHANGES TO IMPROVE LEAD MANUFACTURABILITY.
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