PMA P110042S126
- Device
- EMBLEM Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S126
- Product code
- LWS
- Decision date
- 2019-07-11
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Software change to the automated laser fusion-weld machine used in welding the EMBLEM S-ICD battery case.
Current openFDA PMA Record#
- Device
- EMBLEM Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S126
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2019-07-11
- Decision code
- OK30
- Date received
- 2019-06-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Software change to the automated laser fusion-weld machine used in welding the EMBLEM S-ICD battery case.