PMA P110042S213
- Device
- S-ICD Electrode Model: 3501
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S213
- Product code
- LWS
- Decision date
- 2026-06-03
- Classification
- Cardiovascular
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- the addition of a new controlled environment area (CEA) at the Boston Scientific Dorado, Puerto Rico facility
Current openFDA PMA Record#
- Device
- S-ICD Electrode Model: 3501
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S213
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2026-06-03
- Decision code
- OK30
- Date received
- 2026-05-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the addition of a new controlled environment area (CEA) at the Boston Scientific Dorado, Puerto Rico facility