MARQUIS DR/VR 7274/7230 ICD
FDA premarket approval P980016/S150 · decided 2008-10-24
Approval details
- PMA number
- P980016
- Supplement
- S150
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MARQUIS DR/VR 7274/7230 ICD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2008-08-20
- Decision date
- 2008-10-24
- Days to decision
- 65 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE RV LEAD INTEGRITY ALERT (RVLIA) FEATURE AND MODEL SW012, VERSION 1.1, RVLIA SOFTWARE.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.