OVATIO VR/DR AND PARADYM VR/DR ICDS
FDA premarket approval P980049/S057 · decided 2010-06-28
Approval details
- PMA number
- P980049
- Supplement
- S057
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- OVATIO VR/DR AND PARADYM VR/DR ICDS
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2010-05-17
- Decision date
- 2010-06-28
- Days to decision
- 42 days
- Decision code
- APPR
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR PROGRAMMER SOFTWARE VERSION SMARTVIEW 2.20UG1 FOR USE WITH THE OVATION AND PARADYM ICDS AND CRT-DS AND THE REPLY AND ESPRIT PACEMAKERS.
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