PMA P110042S121
- Device
- Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) EMBLEM S-ICD/MRI S-ICD
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S121
- Product code
- LWS
- Decision date
- 2019-01-23
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Addition of a second supplier for the Hydrogen Getter Sheet Material and a process change to increase the lot size.
Current openFDA PMA Record#
- Device
- Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) EMBLEM S-ICD/MRI S-ICD
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S121
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2019-01-23
- Decision code
- OK30
- Date received
- 2018-12-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a second supplier for the Hydrogen Getter Sheet Material and a process change to increase the lot size.