PMA P910077S154
- Device
- LATITUDE NXT System
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S154
- Product code
- LWS
- Decision date
- 2016-12-12
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Approval for the AUTOGEN ICD and CRT-D systems.
Current openFDA PMA Record#
- Device
- LATITUDE NXT System
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S154
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2016-12-12
- Decision code
- APPR
- Date received
- 2016-06-16
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the AUTOGEN ICD and CRT-D systems.