PARADYM VR MODEL 8250 & DR MODEL 8550
FDA premarket approval P980049/S050 · decided 2010-04-07
Approval details
- PMA number
- P980049
- Supplement
- S050
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PARADYM VR MODEL 8250 & DR MODEL 8550
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2009-09-24
- Decision date
- 2010-04-07
- Days to decision
- 195 days
- Decision code
- APPR
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR THE PARADYM VR MODEL 8250 AND DR MODEL 8550 WITH SMARTVIEW 2.18UG1 PROGRAMMER SOFTWARE AND THE PARADYM CRT-D MODEL 8750 WITH HARDWARE ANDMANUFACTURING CHANGES AND LABELING AND PROGRAMMER SOFTWARE CHANGES TO THE OVATIO VRMODEL 6250, DR MODEL 6550 AND CRT-D MODEL 6750. THE DEVICE, AS MODIFIED, WILL BEMARKETED UNDER THE TRADE NAME PARADYM VR MODEL 8250 AND PARADYM DR MODEL 8550 WITHSMARTVIEW 2.18UG1 AND IS INDICATED FOR USE IN PATIENTS WHO ARE AT HIGH RISK OF SUDDEN CARDIACDEATH DUE TO
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