LATITUDE COMMUNICATOR SOFTWARE & SYSTEM SOFTWARE
FDA premarket approval P910077/S077 · decided 2007-11-06
Approval details
- PMA number
- P910077
- Supplement
- S077
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LATITUDE COMMUNICATOR SOFTWARE & SYSTEM SOFTWARE
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2007-09-05
- Decision date
- 2007-11-06
- Days to decision
- 62 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE LATITUDE COMMUNICATOR SOFTWARE (MODEL 6482), VERSION 2.0 AND RELATED SYSTEM SOFTWARE (MODEL 6488) THAT CONTAINS REGULATED APPLICATION SERVER (RAS) SOFTWARE VERSION 2.3.0 AS WELL AS ASSOCIATED LABELING AND OPERATOR MANUAL UPDATES. THE SOFTWARE MODIFICATIONS ARE INTENDED TO SUPPORT NEW DEVICE MODELS, MAKE MINOR SOFTWARE CORRECTIONS, AND IMPROVE EASE OF USE WITH THE LATITUDE SYSTEM.
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