PMA P910077S068
- Device
- LATITUDE PATIENT MANAGEMENT SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S068
- Product code
- LWS
- Decision date
- 2007-03-23
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order 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.
Current openFDA PMA Record#
- Device
- LATITUDE PATIENT MANAGEMENT SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S068
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2007-03-23
- Decision code
- APPR
- Date received
- 2007-01-11
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.