PMA P110042S162
- Device
- S-ICD GEN 2, S-ICD EMBLEM, EMBLEM S-ICD ELECTRODE
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S162
- Product code
- LWS
- Decision date
- 2021-09-24
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Change the adhesive and liner used on the tray label stock for pulse generators and Leads.
Current openFDA PMA Record#
- Device
- S-ICD GEN 2, S-ICD EMBLEM, EMBLEM S-ICD ELECTRODE
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S162
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2021-09-24
- Decision code
- OK30
- Date received
- 2021-09-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change the adhesive and liner used on the tray label stock for pulse generators and Leads.