PMA P960040S433
- Device
- NG3 Devices
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S433
- Product code
- LWS
- Decision date
- 2019-02-13
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Move the supplier location for fabrication of the Zener diode wafer and to utilize an existing supplier to conduct electrical inspection and dicing of the wafer.
Current openFDA PMA Record#
- Device
- NG3 Devices
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S433
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2019-02-13
- Decision code
- OK30
- Date received
- 2019-02-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Move the supplier location for fabrication of the Zener diode wafer and to utilize an existing supplier to conduct electrical inspection and dicing of the wafer.