PMA P110042S175
- Device
- S-ICD GEN 2, S-ICD EMBLEM MRI
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S175
- Product code
- LWS
- Decision date
- 2022-10-28
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Update the Automated Optical Inspection on the battery feedthrough equipment.
Current openFDA PMA Record#
- Device
- S-ICD GEN 2, S-ICD EMBLEM MRI
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S175
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2022-10-28
- Decision code
- OK30
- Date received
- 2022-10-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update the Automated Optical Inspection on the battery feedthrough equipment.