- Device
- S-ICD, Q-TRAK Subcutaneous Electrode, Q-TECH Programmer and Related Accessories
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S158
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2021-09-24
- Decision code
- OK30
- Date received
- 2021-09-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use a new controlled environment area at the Boston Scientific Dorado, Puerto Rico facility.