MEDTRONIC SECURA DR/VR D224DRG/ D224VRC, MAXIMO DR/VR D284DRG/ D284VRC, VIRTUOSO II DR/VR D274DRG/ D274VRC
FDA premarket approval P980016/S234 · decided 2010-05-11
Approval details
- PMA number
- P980016
- Supplement
- S234
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC SECURA DR/VR D224DRG/ D224VRC, MAXIMO DR/VR D284DRG/ D284VRC, VIRTUOSO II DR/VR D274DRG/ D274VRC
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2010-03-31
- Decision date
- 2010-05-11
- Days to decision
- 41 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR UPDATES MADE TO THE PROGRAMMER APPLICATION SOFTWARE MODEL 9995 AND THE CARELINK DEVICE DATA MANAGEMENT APPLICATION (DDMA) IN RESPONSE TO ADVERSE FIELD EVENTS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.