PMA P110042S139
- Device
- EMBLEM Subcutaneous Implantable Cardioverter Defibrillator S-ICD
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S139
- Product code
- LWS
- Decision date
- 2020-07-22
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Two manufacturing changes to the feedthru underfill dispense process.
Current openFDA PMA Record#
- Device
- EMBLEM Subcutaneous Implantable Cardioverter Defibrillator S-ICD
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S139
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2020-07-22
- Decision code
- OK30
- Date received
- 2020-06-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Two manufacturing changes to the feedthru underfill dispense process.