LATITUDE PATIENT MANAGEMENT SYSTEM
FDA premarket approval P910077/S110 · decided 2011-03-03
Approval details
- PMA number
- P910077
- Supplement
- S110
- 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
- 2011-01-24
- Decision date
- 2011-03-03
- Days to decision
- 38 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR MODIFICATION TO THE LATITUDE PATIENT MANAGEMENT SYSTEM REGULATED APPLICATION SOFTWARE V7.0.02 ON LATITUDE SYSTEM SERVER (MODEL 6488) AND RELATED COMMUNICATOR SOFTWARE CHANGES (MODEL 6476).
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