SECURA DR/VR, VIRTUOSO II DR/VR AND MAXIMO II DR/VR
FDA premarket approval P980016/S175 · decided 2009-03-11
Approval details
- PMA number
- P980016
- Supplement
- S175
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SECURA DR/VR, VIRTUOSO II DR/VR AND MAXIMO II DR/VR
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2009-01-16
- Decision date
- 2009-03-11
- Days to decision
- 54 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE FOLLOWING MINOR DESIGN CHANGES:1) TWO (2) IC DESIGN CHANGES¿ L310 AND L3542) TWO (2) ALTERNATE COMPONENTS¿ DIODE CHANGE (CURRENTLY: XD423 AND PROPOSED: XD445)¿ INSULATED-GATE BIPOLAR TRANSISTOR (IGBT) CHANGE (CURRENTLY: XD405 ANDPROPOSED: XD447)3) PRINTED WIRE BOARD (PWB) CHANGES TO ACCOMMODATE THE ALTERNATE (XD445 DIODE ANDXD447 IGBT) COMPONENTS AND MANUFACTURABILITY IMPROVEMENTS.4) FOUR (4) ICS (L303, L310, L354, AND L409) TO BE TRANSFERRED TO AN ALTERNATIVE ICFABRICATION VEND
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