PMA P110042S167
- Device
- Subcutaneous ICD Devices
- Applicant
- Boston Scientific Corporation
- Product code
- LWS
- Decision date
- 2022-02-24
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Approval for a software maintenance release for updates to the Model 3300 LATITUDE Programming System software.
Current openFDA PMA Record#
- Device
- Subcutaneous ICD Devices
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S167
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2022-02-24
- Decision code
- APPR
- Date received
- 2021-12-01
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a software maintenance release for updates to the Model 3300 LATITUDE Programming System software.