LATITUDE Programming System
FDA premarket approval P910077/S186 · decided 2021-11-30
Approval details
- PMA number
- P910077
- Supplement
- S186
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LATITUDE Programming System
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2021-09-03
- Decision date
- 2021-11-30
- Days to decision
- 88 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) to the Model 3300 LATITUDE Programming System and the release of the Model 3894 LATITUDE Consult software application.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.