PMA P110042S107
- Device
- EMBLEM MRI S-CD/ EMBLEM S-CD Pulse Generator (PG)
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S107
- Product code
- LWS
- Decision date
- 2018-05-15
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Add Boston Scientific as a second supplier for Digital ASIC electrical testing and to implement other minor process updates.
Current openFDA PMA Record#
- Device
- EMBLEM MRI S-CD/ EMBLEM S-CD Pulse Generator (PG)
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S107
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2018-05-15
- Decision code
- OK30
- Date received
- 2018-04-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add Boston Scientific as a second supplier for Digital ASIC electrical testing and to implement other minor process updates.