OVATIO DR AND VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
FDA premarket approval P980049/S062 · decided 2011-02-10
Approval details
- PMA number
- P980049
- Supplement
- S062
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- OVATIO DR AND VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2010-12-16
- Decision date
- 2011-02-10
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR THE CHANGES OF THE TRANSFORMER (T413), OPTO WEDGE (G309), AND DESICCANT (J907) FOR THE PARADYM ICD AND CRT-D MODELS 8250, 8550, AND 8750.
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