PMA P110042S045
- Device
- EMBLEM SUBCUTANEOUS ICD
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S045
- Product code
- LWS
- Decision date
- 2015-07-21
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR SOFTWARE UPDATES TO THE LATITUDE NXT PATIENT MANAGEMENT SYSTEM (RELEASE 4.0).
Current openFDA PMA Record#
- Device
- EMBLEM SUBCUTANEOUS ICD
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S045
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2015-07-21
- Decision code
- APPR
- Date received
- 2015-04-27
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR SOFTWARE UPDATES TO THE LATITUDE NXT PATIENT MANAGEMENT SYSTEM (RELEASE 4.0).