PRIZM & VITALITY PG CONFIENT ICD
FDA premarket approval P960040/S156 · decided 2008-01-30
Approval details
- PMA number
- P960040
- Supplement
- S156
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PRIZM & VITALITY PG CONFIENT ICD
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2007-12-11
- Decision date
- 2008-01-30
- Days to decision
- 50 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- 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.
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