Latitude Programming System
FDA premarket approval P910077/S165 · decided 2018-03-26
Approval details
- PMA number
- P910077
- Supplement
- S165
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Latitude Programming System
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2018-01-18
- Decision date
- 2018-03-26
- Days to decision
- 67 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for a Software Maintenance Release (SMR) for the Model 3922 Pacing System Analyzer (PSA) Software Application that functions within the Model 3300 LATITUDE Programming System (LPS).
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