OVATIO DR AND VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
FDA premarket approval P980049/S061 · decided 2012-12-21
Approval details
- PMA number
- P980049
- Supplement
- S061
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- OVATIO DR AND VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2010-11-29
- Decision date
- 2012-12-21
- Days to decision
- 753 days
- Decision code
- APPR
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR UPDATING THE LABELING OF THE DEVICES BASED ON THE POST-APPROVAL STUDY RESULTS.
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