PMA P110042S156
- Device
- SICD Gen 2, SICD MRI
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S156
- Product code
- LWS
- Decision date
- 2021-04-30
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Update test software to include an additional Bill of Materials check for all pulse generator devices.
Current openFDA PMA Record#
- Device
- SICD Gen 2, SICD MRI
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S156
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2021-04-30
- Decision code
- OK30
- Date received
- 2021-04-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update test software to include an additional Bill of Materials check for all pulse generator devices.