- Device
- MULTIPLE APPLICATION UTILITY MODEL 2909 (FROM V9.03 TO V9.04)
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S155
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2017-07-06
- Decision code
- APPR
- Date received
- 2016-10-19
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the Automated Screening Tool software to aide in determining whether the S-ICD System is appropriate.