LATITUDE Programming System (Programmer)
FDA premarket approval P910077/S181 · decided 2020-09-17
Approval details
- PMA number
- P910077
- Supplement
- S181
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LATITUDE Programming System (Programmer)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2020-08-24
- Decision date
- 2020-09-17
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Implement new flux and solder materials for use in the manufacture of the Model 3300 LATITUDE Programming System, Model 6395 Telemetry Wand, and Model 3200 EMBLEM S-ICD Programmer as part of the manufacturing process.
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