PMA P110042S070
- Device
- SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM EMBLEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S070
- Product code
- LWS
- Decision date
- 2017-02-16
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Approval for Model 6290 Patient Communicator software update to version 2.22.00.
Current openFDA PMA Record#
- Device
- SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM EMBLEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S070
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2017-02-16
- Decision code
- APPR
- Date received
- 2016-11-22
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for Model 6290 Patient Communicator software update to version 2.22.00.