PMA P960040S440
- Device
- Autogen, Dynagen, Inogen, and Origen NG3 ICDs and Resonate, Momentum, Vigilant, and Perciva NG4 ICDs
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S440
- Product code
- LWS
- Decision date
- 2019-09-18
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Approval for hardware modifications to the IS-1 lead bore cavity and spring coil in the IS-1 pulse generator (PG) header for all pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps) within the Accolade family and a subset of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-D) within the NG3 and NG4 families.
Current openFDA PMA Record#
- Device
- Autogen, Dynagen, Inogen, and Origen NG3 ICDs and Resonate, Momentum, Vigilant, and Perciva NG4 ICDs
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S440
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2019-09-18
- Decision code
- APPR
- Date received
- 2019-06-20
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for hardware modifications to the IS-1 lead bore cavity and spring coil in the IS-1 pulse generator (PG) header for all pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps) within the Accolade family and a subset of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-D) within the NG3 and NG4 families.