VIRTUOSO,MARQUIS,MAXIMO,INTRINSIC & ENTRUST ICDS
FDA premarket approval P980016/S101 · decided 2007-06-25
Approval details
- PMA number
- P980016
- Supplement
- S101
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VIRTUOSO,MARQUIS,MAXIMO,INTRINSIC & ENTRUST ICDS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2007-04-24
- Decision date
- 2007-06-25
- Days to decision
- 62 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE L325-03 AND L325-04 INTEGRATED CIRCUIT (IC) TO MINIMIZE THE POTENTIAL FOR A GATE-OXIDE BREAKDOWN WITHIN THE L325-01, L325-02, AND L281-04 ICS.
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