OVATIO VR 6250 & DR 6550
FDA premarket approval P980049/S041 · decided 2009-02-03
Approval details
- PMA number
- P980049
- Supplement
- S041
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- OVATIO VR 6250 & DR 6550
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2008-08-21
- Decision date
- 2009-02-03
- Days to decision
- 166 days
- Decision code
- APPR
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR THE IGBT (PART NUMBER 10N170) TO BE USED IN THE SHOCK 6 HYBRID MODULE T273 (SCOT273) FOR THE OVATIO ICD AND CRT DEVICES.
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