LATITUDE PACEART INTEGRATION SYSTEM
FDA premarket approval P910077/S084 · decided 2008-03-17
Approval details
- PMA number
- P910077
- Supplement
- S084
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LATITUDE PACEART INTEGRATION SYSTEM
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2008-02-28
- Decision date
- 2008-03-17
- Days to decision
- 18 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE LATITUDE PACEART INTEGRATION (LPI) (MODEL 6472 V1.0) THAT WILL RESIDE ON THE LATITUDE PATIENT MANAGEMENT SYSTEM (MODEL 6488 V4.0).
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