PMA P110042S172
- Device
- EMBLEM™ S-ICD, EMBLEM MRI S ICD
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S172
- Product code
- LWS
- Decision date
- 2022-09-27
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Implement an automatic handling system for the helium leak test process.
Current openFDA PMA Record#
- Device
- EMBLEM™ S-ICD, EMBLEM MRI S ICD
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S172
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2022-09-27
- Decision code
- OK30
- Date received
- 2022-09-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement an automatic handling system for the helium leak test process.