MAXIMO II DF4 ICD, SECURA DF4 ICD
FDA premarket approval P980016/S362 · decided 2012-09-12
Approval details
- PMA number
- P980016
- Supplement
- S362
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MAXIMO II DF4 ICD, SECURA DF4 ICD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2012-06-14
- Decision date
- 2012-09-12
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE USE OF RECENTLY APPROVED SOFTWARE 9995 VERSION 7.4 AND ASSOCIATED DDMA SOFTWARE 2491 WITH RECENTLY APPROVED DEVICE MODELS D264VRM AND D204VRM.
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