ENTRUST, VIRTUOSO, INTRINSIC, MARQUIS, MAXIMO, MAXIMO II, SECURA, VIRTUOSO II. INSYNC MARQUIS, PROTECTA/ PROTECTA XT DR
FDA premarket approval P980016/S547 · decided 2015-10-07
Approval details
- PMA number
- P980016
- Supplement
- S547
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ENTRUST, VIRTUOSO, INTRINSIC, MARQUIS, MAXIMO, MAXIMO II, SECURA, VIRTUOSO II. INSYNC MARQUIS, PROTECTA/ PROTECTA XT DR
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2015-08-28
- Decision date
- 2015-10-07
- Days to decision
- 40 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE FIRMWARE UPDATES FOR THE HOME MONITOR SYSTEMS, WHICH WILL BE USED WITH THE IMPLANTABLE DEVICES.
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