MEDTRONIC VIRTUOSO ICD (MODELS D154AWG AND D154VWC)
FDA premarket approval P980016/S102 · decided 2007-06-06
Approval details
- PMA number
- P980016
- Supplement
- S102
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC VIRTUOSO ICD (MODELS D154AWG AND D154VWC)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2007-05-16
- Decision date
- 2007-06-06
- Days to decision
- 21 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A CHANGE IN THE BAROMETRIC PRESSURE REQUIREMENT FROM 6 ATMOSPHERES ABSOLUTE (ATA) TO 4 ATA AND A CHANGE IN BAROMETRIC PRESSURE TESTING METHODOLOGY USED DURING DESIGN VERIFICATION.
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