- Device
- ICD ORIGEN CRT-D, ICD INOGEN CRT-D, ICD DYNAGEN CRT-D, ICD AUTOGEN CRT-D
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S544
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2021-09-20
- Decision code
- OK30
- Date received
- 2021-09-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update the general visual inspection criteria for cathode damage observed during high voltage capacitor manufacturing used in NG3 ICDs and CRT-Ds.