MEDTRONIC ICD MODEL INSYNC 7272 SYSTEM
FDA premarket approval P010031/S073 · decided 2007-09-13
Approval details
- PMA number
- P010031
- Supplement
- S073
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MEDTRONIC ICD MODEL INSYNC 7272 SYSTEM
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2007-07-12
- Decision date
- 2007-09-13
- Days to decision
- 63 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A LABELING UPDATE TO ADD A CLINICAL SUMMARY FOR THE COMPLETED INSYNC ICD MODEL 171 POST-APPROVAL STUDY.
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