PMA P960040S390
- Device
- Implantable Cardioverter Defibrilllator/ Dynagen, Inogen, Origen and Autogen ICD's.
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S390
- Product code
- LWS
- Decision date
- 2017-05-18
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Approval for addition of alternate bondply adhesive suppliers for pulse generator Super Output Module (SOM) and High Voltage Charge (HVC) module substrates.
Current openFDA PMA Record#
- Device
- Implantable Cardioverter Defibrilllator/ Dynagen, Inogen, Origen and Autogen ICD's.
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S390
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2017-05-18
- Decision code
- APPR
- Date received
- 2017-03-06
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for addition of alternate bondply adhesive suppliers for pulse generator Super Output Module (SOM) and High Voltage Charge (HVC) module substrates.