- Device
- ICD ORIGEN CRT-D, MOMENTUM CRT-D, MOMENTUM X4 CRT-D, ICD INOGEN CRT-D, ICD DYNAGEN CRT-D, ICD AUTOGEN CRT-D, VIGILANT CR
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S523
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2020-10-01
- Decision code
- OK30
- Date received
- 2020-09-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Relocate several manufacturing steps for Tachy, Brady, and S-ICD's.