MODEL 7303 INSYNC MAXIMO DUAL CHAMBER ICD SYSTEM AND MODEL 9998 APPLICATION SOFTWARE VERSION 1.0 FOR THE MODEL 2090 PROG
FDA premarket approval P010031/S013 · decided 2004-06-23
Approval details
- PMA number
- P010031
- Supplement
- S013
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODEL 7303 INSYNC MAXIMO DUAL CHAMBER ICD SYSTEM AND MODEL 9998 APPLICATION SOFTWARE VERSION 1.0 FOR THE MODEL 2090 PROG
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2004-05-10
- Decision date
- 2004-06-23
- Days to decision
- 44 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- MODEL 7303 INSYNC MAXIMO DUAL CHAMBER ICD SYSTEM AND MODEL 9998 APPLICATION SOFTWARE VERSION 1.0 FOR THE MODEL 2090 PROGRAMMER SYSTEM.
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