PMA P110042S166
- Device
- Subcutaneous Implantable Cardiac Defibrillators, Emblem™ MRI S-ICD, Emblem™ S-ICD
- Applicant
- Boston Scientific Corporation
- Product code
- LWS
- Decision date
- 2021-12-29
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Add a sensor to battery manufacturing equipment to prevent device defects.
Current openFDA PMA Record#
- Device
- Subcutaneous Implantable Cardiac Defibrillators, Emblem™ MRI S-ICD, Emblem™ S-ICD
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S166
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2021-12-29
- Decision code
- OK30
- Date received
- 2021-11-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add a sensor to battery manufacturing equipment to prevent device defects.