- Device
- TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT and PERCIVA ICD Devic
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S437
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2019-07-08
- Decision code
- APPR
- Date received
- 2019-04-10
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval to modify the Model 3300 LATITUDE Programming System software components.