SECURA, VIRTUOSO II & MAXIMO II
FDA premarket approval P980016/S255 · decided 2010-10-29
Approval details
- PMA number
- P980016
- Supplement
- S255
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SECURA, VIRTUOSO II & MAXIMO II
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2010-07-20
- Decision date
- 2010-10-29
- Days to decision
- 101 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE DESIGN CHANGES TO X7R-0805 MULTILAYER CERAMIC CAPACITORS (XC194 AND XC291).
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