PMA P960040S436
- Device
- ICD Devices TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIVA
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S436
- Product code
- LWS
- Decision date
- 2019-06-10
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Approval for hardware changes to the Latitude NXT Patient Management System Communicators.
Current openFDA PMA Record#
- Device
- ICD Devices TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIVA
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S436
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2019-06-10
- Decision code
- APPR
- Date received
- 2019-03-20
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for hardware changes to the Latitude NXT Patient Management System Communicators.