PMA P110042S109
- Device
- S-ICD Battery Anode Laser Edge Weld Process
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S109
- Product code
- LWS
- Decision date
- 2018-05-08
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Modification to the S-ICD battery anode laser weld process.
Current openFDA PMA Record#
- Device
- S-ICD Battery Anode Laser Edge Weld Process
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S109
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2018-05-08
- Decision code
- OK30
- Date received
- 2018-05-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modification to the S-ICD battery anode laser weld process.