PMA P110042S117
- Device
- EMBLEM S-ICD Pulse Generator; EMBLEM MRI S-ICD Pulse Generator
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S117
- Product code
- LWS
- Decision date
- 2018-12-06
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Changes to test equipment software which performs acceptance activity inspections on the hybrid.
Current openFDA PMA Record#
- Device
- EMBLEM S-ICD Pulse Generator; EMBLEM MRI S-ICD Pulse Generator
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S117
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2018-12-06
- Decision code
- OK30
- Date received
- 2018-11-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to test equipment software which performs acceptance activity inspections on the hybrid.