- Device
- EMBLEM S-ICD Pulse Generator
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S140
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2020-08-06
- Decision code
- OK30
- Date received
- 2020-07-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change suppliers, update manufacturing procedures, and update test protocols for the flash memory component used in EMBLEM S-ICD Pulse Generators.