PMA P010012S497
- Device
- NG4 Devices
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S497
- Product code
- NIK
- Decision date
- 2019-02-13
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- 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
- NG4 Devices
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S497
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- 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.