PMA P960040S401
- Device
- ICDS: ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE HF ICD, RESONATE EL ICD, MOMENTUM EL ICD, VIGILIANT EL ICD, PERCIVA HF
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S401
- Product code
- LWS
- Decision date
- 2017-08-30
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Modifications to the manufacturing process for the spring contact housing components.
Current openFDA PMA Record#
- Device
- ICDS: ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE HF ICD, RESONATE EL ICD, MOMENTUM EL ICD, VIGILIANT EL ICD, PERCIVA HF
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S401
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2017-08-30
- Decision code
- OK30
- Date received
- 2017-08-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications to the manufacturing process for the spring contact housing components.