PMA P110042S108
- Device
- S-ICD Pulse Generator, Emblem S-ICD, Emblem MRI S-ICD
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S108
- Product code
- LWS
- Decision date
- 2018-06-01
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Add an additional supplier for the raw stainless steel material for battery interconnect tabs used in Tachy and Subcutaneous Implantable Cardioverter Defibrillator pulse generator devices.
Current openFDA PMA Record#
- Device
- S-ICD Pulse Generator, Emblem S-ICD, Emblem MRI S-ICD
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S108
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2018-06-01
- Decision code
- OK30
- Date received
- 2018-05-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add an additional supplier for the raw stainless steel material for battery interconnect tabs used in Tachy and Subcutaneous Implantable Cardioverter Defibrillator pulse generator devices.