Subcutaneous ICD Devices: EMBLEM S-ICD
FDA premarket approval P110042/S133 · decided 2020-04-01
Approval details
- PMA number
- P110042
- Supplement
- S133
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Subcutaneous ICD Devices: EMBLEM S-ICD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific Corporation
- Date received
- 2020-01-03
- Decision date
- 2020-04-01
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for software changes included in LATITUDE NXT Patient Management System, Release 6.1.5 and associated changes in Server and Communicator software updates.
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