MEDTRONIC INSYNC MARQUIS MODEL 7277 DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WITH CARDIAC RESYNCHRONIZATION 3
FDA premarket approval P010031/S003 · decided 2003-03-27
Approval details
- PMA number
- P010031
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC INSYNC MARQUIS MODEL 7277 DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WITH CARDIAC RESYNCHRONIZATION 3
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2002-11-13
- Decision date
- 2003-03-27
- Days to decision
- 134 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE MEDTRONIC INSYNC MARQUIS MODEL 7277 DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WITH CARDIAC RESYNCHRONIZATION THERAPY AND INSYNC MARQUIS APPLICATION SOFTWARE MODEL 9983 AND FOR THE SYSTEM TO BE MANUFACTURED AT MED REL, HUMACACO, PUERTO, RICO, MEDTRONIC, EUROPE S.A, TOLOCHENAZ, SWITZERLAND AND MEDTRONIC BV, KERKRADE, THE NETHERLANDS.
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