PMA P110042S114
- Device
- Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) Electrode
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S114
- Product code
- LWS
- Decision date
- 2018-10-24
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Add the "first-half" of the EMBLEM S-ICD lead manufacturing line at the Dorado Site.
Current openFDA PMA Record#
- Device
- Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) Electrode
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S114
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2018-10-24
- Decision code
- OK30
- Date received
- 2018-09-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add the "first-half" of the EMBLEM S-ICD lead manufacturing line at the Dorado Site.