PMA P960040S428
- Device
- Dynagen Mini ICD, Inogen Mini/EL ICD, Origen Mini/EL ICD, Dynagen EL ICD, Autogen EL ICD, Vigilant EL ICD, Perciva ICD,
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S428
- Product code
- LWS
- Decision date
- 2018-09-04
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Addition of an alternate supplier for the molybdenum feedthru pin.
Current openFDA PMA Record#
- Device
- Dynagen Mini ICD, Inogen Mini/EL ICD, Origen Mini/EL ICD, Dynagen EL ICD, Autogen EL ICD, Vigilant EL ICD, Perciva ICD,
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S428
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2018-09-04
- Decision code
- OK30
- Date received
- 2018-08-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an alternate supplier for the molybdenum feedthru pin.