OVATIO VR 6250 AND OVATIO DR 6550
FDA premarket approval P980049/S040 · decided 2008-10-31
Approval details
- PMA number
- P980049
- Supplement
- S040
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- OVATIO VR 6250 AND OVATIO DR 6550
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2008-08-13
- Decision date
- 2008-10-31
- Days to decision
- 79 days
- Decision code
- APPR
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR A MODIFICATION TO THE AUTOMATIC SENSITIVITY CONTROL (ASC) ALGORITHM IN THE OVATIO VR 6250, OVATIO DR 6550 AND OVATIO CRT 6750.
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