PMA P110042S059
- Device
- SUBCUTANEOUS ICD DEVICES: EMBLEM.
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S059
- Product code
- LWS
- Decision date
- 2016-07-08
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Approval for LATITUDE NXT Patient Management System, Release 4.1.1.
Current openFDA PMA Record#
- Device
- SUBCUTANEOUS ICD DEVICES: EMBLEM.
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S059
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2016-07-08
- Decision code
- APPR
- Date received
- 2016-04-21
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for LATITUDE NXT Patient Management System, Release 4.1.1.