- Device
- RESONATE, VIGILANT, PERCIVA NG4 ICDs AUTOGEN, DYNAGEN, INOGEN, ORIGEN NG3 ICDs
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S395
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2017-09-20
- Decision code
- APPR
- Date received
- 2017-05-26
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval to label a subset of the market released devices as ImageReady MR Conditional Defibrillation System.