ENTRUST ICD
FDA premarket approval P980016/S191 · decided 2009-06-24
Approval details
- PMA number
- P980016
- Supplement
- S191
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ENTRUST ICD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2009-03-27
- Decision date
- 2009-06-24
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR VERSION 7.1 OF THE MODEL 9987 APPLICATION SOFTWARE WHICH RESETS THE ERI VOLTAGE THRESHOLD TO COMPENSATE FOR THE POTENTIAL PREMATURE LITHIUM DEPLETION.
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