INSYNC MARQUIS MODEL 7277 DUAL CHAMBER ICD SYSTEM
FDA premarket approval P010031/S006 · decided 2003-04-24
Approval details
- PMA number
- P010031
- Supplement
- S006
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Express GMP Supplement
- Trade name
- INSYNC MARQUIS MODEL 7277 DUAL CHAMBER ICD SYSTEM
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2003-04-01
- Decision date
- 2003-04-24
- Days to decision
- 23 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT EUROPEAN OPERATIONS CENTER, MEDTRONIC B.V., HEERLEN, THE NETHERLANDS. FINAL DEVICE PACKAGING WILL BE PERFORMED AT THIS FACILITY.
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