LATITUDE PATIENT MANAGEMENT SYSTEM SOFTWARE
FDA premarket approval P910077/S071 · decided 2007-03-28
Approval details
- PMA number
- P910077
- Supplement
- S071
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LATITUDE PATIENT MANAGEMENT SYSTEM SOFTWARE
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2007-01-16
- Decision date
- 2007-03-28
- Days to decision
- 71 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE LATITUDE SYSTEM SOFTWARE, VERSION 2.1 (MODEL 6488) THAT CONTAINS REGULATED APPLICATION SERVER (RAS) SOFTWARE, VERSION 2.1.1 AND WEB APPLICATION SERVER (WAS) SOFTWARE, VERSION 2.1.1.
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