ISOLINE 2CR DEFIBRILLATION LEADS MODELS 2CR5, 2CR6 AND 2CR7
FDA premarket approval P980049/S024 · decided 2008-01-09
Approval details
- PMA number
- P980049
- Supplement
- S024
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ISOLINE 2CR DEFIBRILLATION LEADS MODELS 2CR5, 2CR6 AND 2CR7
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2006-10-16
- Decision date
- 2008-01-09
- Days to decision
- 450 days
- Decision code
- APPR
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR THE ISOLINE 2CT DEFIBRILLATION LEADS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ISOLINE 2CT5 & 2CT6 TRANSVENOUS DEFIBRILLATION LEADS AND IS INDICATED TO PROVIDE RIGHT VENTRICULAR PACING, SENSING AND DEFIBRILLATION WHEN USED AS PART OF AN ELA MEDICAL IMPLANTABLE DEFIBRILLATOR.
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