PMA P960040S391
- Device
- Teligen, Energen, Puntua, Incepta, Origen, Inogen, Dynagen, Autogen
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S391
- Product code
- LWS
- Decision date
- 2017-09-11
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Approval for the Model 3300 LATITUDE Programming System.
Current openFDA PMA Record#
- Device
- Teligen, Energen, Puntua, Incepta, Origen, Inogen, Dynagen, Autogen
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S391
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2017-09-11
- Decision code
- APPR
- Date received
- 2017-04-03
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the Model 3300 LATITUDE Programming System.