PMA P960040S403
- Device
- ICDs: Origen, Inogen, Dynagen, Momentum EL ICD, Autogen, Vigiliant EL ICD, Perciva ICD, Resonate EL ICD, Perciva HF ICD,
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S403
- Product code
- LWS
- Decision date
- 2017-09-25
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Modify the quartz crystal component manufacturing process.
Current openFDA PMA Record#
- Device
- ICDs: Origen, Inogen, Dynagen, Momentum EL ICD, Autogen, Vigiliant EL ICD, Perciva ICD, Resonate EL ICD, Perciva HF ICD,
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S403
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2017-09-25
- Decision code
- OK30
- Date received
- 2017-09-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modify the quartz crystal component manufacturing process.