MEDTRONIC MODELS 7230CX, 7230B, AND 7230E MARQUIS VR SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS WITH
FDA premarket approval P980016/S029 · decided 2002-12-17
Approval details
- PMA number
- P980016
- Supplement
- S029
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC MODELS 7230CX, 7230B, AND 7230E MARQUIS VR SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS WITH
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2002-06-28
- Decision date
- 2002-12-17
- Days to decision
- 172 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR MEDTRONIC MODELS 7230CX, 7230B, AND 7230E MARQUIS VR SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEMS WITH MODEL 9967 (MARQUIS VR) APPLICATION SOFTWARE FOR USE WITH THE COMMERCIALLY AVAILABLE MODEL 9322 PATIENT MAGNET, THE MODEL 9790C PROGRAMMING SYSTEM [9790C PROGRAMMER, MODEL 9990 DESKTOP SOFTWARE AND MODEL 9767/9767L TELEMETRY PROGRAMMING HEAD (TELEMETRY B)] AND WITH THE MODEL 2090 PROGRAMMING SYSTEM [2090 PROGRAMMER, MODEL 9986 DESKTOP SOFTWARE AND MODEL 2067/
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