PMA P110042S142
- Device
- EMBLEM S-ICD - Subcutaneous Devices
- Applicant
- Boston Scientific Corporation
- Product code
- LWS
- Decision date
- 2020-10-22
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Approval for software changes included in LATITUDE NXT Patient Management System Release 7.0.
Current openFDA PMA Record#
- Device
- EMBLEM S-ICD - Subcutaneous Devices
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S142
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2020-10-22
- Decision code
- APPR
- Date received
- 2020-08-06
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for software changes included in LATITUDE NXT Patient Management System Release 7.0.