PARADYM ICDS AND CRT-D DEVICES
FDA premarket approval P980049/S060 · decided 2010-09-08
Approval details
- PMA number
- P980049
- Supplement
- S060
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PARADYM ICDS AND CRT-D DEVICES
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2010-08-12
- Decision date
- 2010-09-08
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR THE DESIGN CHANGES FOR LOW VOLTAGE ELECTRONIC HYBRID MODULE AND INTERCONNECTION FLEX CIRCUIT FOR PARADYM VR/DR AND CRT-D, MODELS 8250, 8550, AND 8750.
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