PMA P110042S145
- Device
- Subcutaneous Implantable Cardioverter Defibrillator
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S145
- Product code
- LWS
- Decision date
- 2020-09-10
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Add a 30-minute dwell time step after all sterilization loads for S-ICD pulse generators.
Current openFDA PMA Record#
- Device
- Subcutaneous Implantable Cardioverter Defibrillator
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S145
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2020-09-10
- Decision code
- OK30
- Date received
- 2020-08-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add a 30-minute dwell time step after all sterilization loads for S-ICD pulse generators.