PMA P910077S083
- Device
- VARIOUS ICD FAMILIES & LATITUDE COMMUNICATOR
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S083
- Product code
- LWS
- Decision date
- 2008-01-30
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR THE LATITUDE COMMUNICATOR SOFTWARE (MODEL 6482) VERSION 2.1 AND RELATED SYSTEM SOFTWARE (MODEL 6488) THAT CONTAINS REGULATED APPLICATION SERVER (RAS) SOFTWARE VERSION 2.40 AS WELL AS ASSOCIATED LABELING AND OPERATOR MANUAL UPDATES. THE SOFTWARE MODIFICATIONS ARE INTENDED TO SUPPORT NEW DEVICE MODELS (LIVIAN), MAKE MINOR SOFTWARE CORRECTIONS, AND IMPROVE EASE OF USE WITH THE LATITUDE SYSTEM.
Current openFDA PMA Record#
- Device
- VARIOUS ICD FAMILIES & LATITUDE COMMUNICATOR
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S083
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2008-01-30
- Decision code
- APPR
- Date received
- 2007-12-11
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE LATITUDE COMMUNICATOR SOFTWARE (MODEL 6482) VERSION 2.1 AND RELATED SYSTEM SOFTWARE (MODEL 6488) THAT CONTAINS REGULATED APPLICATION SERVER (RAS) SOFTWARE VERSION 2.40 AS WELL AS ASSOCIATED LABELING AND OPERATOR MANUAL UPDATES. THE SOFTWARE MODIFICATIONS ARE INTENDED TO SUPPORT NEW DEVICE MODELS (LIVIAN), MAKE MINOR SOFTWARE CORRECTIONS, AND IMPROVE EASE OF USE WITH THE LATITUDE SYSTEM.