MEDTRONIC VIRTUOSO MODEL D154AWG/ D154VWC IMPLANTABLE DEVICES
FDA premarket approval P980016/S084 · decided 2006-11-15
Approval details
- PMA number
- P980016
- Supplement
- S084
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC VIRTUOSO MODEL D154AWG/ D154VWC IMPLANTABLE DEVICES
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2006-08-24
- Decision date
- 2006-11-15
- Days to decision
- 83 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR SOFTWARE VERSION 1.1 WHICH ADDRESSES AN ISSUE OF TEMPERATURE SENSITIVITY ON TELEMETRY.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.