LATITUDE PATIENT MANAGEMENT SYSTEM
FDA premarket approval P910077/S068 · decided 2007-03-23
Approval details
- PMA number
- P910077
- Supplement
- S068
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LATITUDE PATIENT MANAGEMENT SYSTEM
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2007-01-11
- Decision date
- 2007-03-23
- Days to decision
- 71 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR SOFTWARE UPDATES TO 1) CHANGE THE CURRENT WEIGHT ALERT ALGORITHM TO REDUCE OVER-REPORTING OF WEIGHT ALERTS; AND 2) TO CORRECT A DETECTION FAILURES DUE TO DIFFERING TIME ZONE CHANGES.
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