OVATIO VR/DR
FDA premarket approval P980049/S053 · decided 2010-04-27
Approval details
- PMA number
- P980049
- Supplement
- S053
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- OVATIO VR/DR
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2010-02-04
- Decision date
- 2010-04-27
- Days to decision
- 82 days
- Decision code
- APPR
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR A CHANGE TO THE SOLDERING AND CLEANING PROCESSES FOR THE SHOCK 6 HYBRID MODULES.
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