ENTRUST DR/VR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
FDA premarket approval P980016/S173 · decided 2009-02-13
Approval details
- PMA number
- P980016
- Supplement
- S173
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ENTRUST DR/VR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2008-12-24
- Decision date
- 2009-02-13
- Days to decision
- 51 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR AN UPDATED TO THE APPROVED LEAD INTEGRITY ALERT (LIA) SOFTWARE APPLICATION MODEL SW01 WHICH CORRECTS AN UNINTENDED INTERACTION BETWEEN THE ENTRUST DR/VR ICDS AND LIA.
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