MEDTRONIC INSYNC ICD MODEL 7272 AND MODEL 9969 APPLICATION SOFTWARE
FDA premarket approval P010031/S012 · decided 2004-05-28
Approval details
- PMA number
- P010031
- Supplement
- S012
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- MEDTRONIC INSYNC ICD MODEL 7272 AND MODEL 9969 APPLICATION SOFTWARE
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2004-01-28
- Decision date
- 2004-05-28
- Days to decision
- 121 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR 1) CHANGES TO THE INVESTIGATIONAL PLAN AND IMPLANT FORMS OF THE POST-APPROVAL STUDY AND 2) THE ADDITION OF THE INSYNC MODEL 7277 WITH MODEL 9983 APPLICATION SOFTWARE TO THE STUDY.
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