OVATIO DR & OVATIO VR ICDS
FDA premarket approval P980049/S034 · decided 2008-04-25
Approval details
- PMA number
- P980049
- Supplement
- S034
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- OVATIO DR & OVATIO VR ICDS
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2008-02-26
- Decision date
- 2008-04-25
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
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