OVATIO VR 6250 & OVATIO DR 6550
FDA premarket approval P980049/S054 · decided 2010-03-12
Approval details
- PMA number
- P980049
- Supplement
- S054
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- OVATIO VR 6250 & OVATIO DR 6550
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2010-02-12
- Decision date
- 2010-03-12
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- CHANGING FROM MANUAL TO AUTOMATED CLEANING PROCESS.
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