PMA P110042S127
- Device
- Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) pulse generator (PG) high voltage (HV) capacitor stack
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S127
- Product code
- LWS
- Decision date
- 2019-09-13
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Update to the 100% human visual inspection criteria for S-ICD pulse generator high voltage capacitor stacks.
Current openFDA PMA Record#
- Device
- Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) pulse generator (PG) high voltage (HV) capacitor stack
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S127
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2019-09-13
- Decision code
- OK30
- Date received
- 2019-08-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update to the 100% human visual inspection criteria for S-ICD pulse generator high voltage capacitor stacks.