PMA P110042S149
- Device
- S-ICD GEN 2 and S-ICD EMBLEM MRI
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S149
- Product code
- LWS
- Decision date
- 2020-11-05
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Add a lubricant to the battery cathode tab punching process.
Current openFDA PMA Record#
- Device
- S-ICD GEN 2 and S-ICD EMBLEM MRI
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S149
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2020-11-05
- Decision code
- OK30
- Date received
- 2020-11-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add a lubricant to the battery cathode tab punching process.