PMA P110042S068
- Device
- EMBLEM SUBCUTANEOUS ICD's
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S068
- Product code
- LWS
- Decision date
- 2017-04-17
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Approval for the LATITUDE NXT Patient Management System Release 5.0.
Current openFDA PMA Record#
- Device
- EMBLEM SUBCUTANEOUS ICD's
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S068
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2017-04-17
- Decision code
- APPR
- Date received
- 2016-10-26
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the LATITUDE NXT Patient Management System Release 5.0.