SELECTED FAMILIES OF ICD'S
FDA premarket approval P980016/S071 · decided 2006-04-21
Approval details
- PMA number
- P980016
- Supplement
- S071
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SELECTED FAMILIES OF ICD'S
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2006-02-21
- Decision date
- 2006-04-21
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE SESSIONSYNC FEATURE AS PART OF AN ENHANCEMENT TO MODEL 9986 DESKTOP / BASELINE OPERATING SYSTEM SOFTWARE (BOSS) VERSIONS 1.3.8/1.5 FOR THE 2090 CARELINK PROGRAMMER. SESSIONSYNC ALLOWS DATA TRANSFER BETWEEN THE MODEL 2090 CARELINK PROGRAMMER AND THE CUSTOMER'S PACEART SYSTEM (A DATA MANAGEMENT SYSTEM).
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