LATTITUDE CONSULT SYSTEM
FDA premarket approval P910077/S138 · decided 2014-03-20
Approval details
- PMA number
- P910077
- Supplement
- S138
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LATTITUDE CONSULT SYSTEM
- Generic name
- Pacemaker/icd/crt non-implanted components
- Applicant
- Boston Scientific
- Date received
- 2013-09-25
- Decision date
- 2014-03-20
- Days to decision
- 176 days
- Decision code
- APPR
- Product code
- OSR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE LATITUDE CONSULT SYSTEM WHICH INCLUDES THE COMMUNICATOR MODEL 6299 AND APPLICATION SOFTWARE SERVER MODEL 6294.
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