- Device
- SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S004
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2013-02-21
- Decision code
- APPR
- Date received
- 2013-01-11
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR A CHANGE TO THE PATIENT SCREENING INSTRUCTIONS IN THE SQ-RX PULSE GENERATOR USER MANUAL.