PMA P960040S472
- Device
- ORIGEN MINI ICD VR, ORIGEN MINI ICD DR, INOGEN™ MINI ICD VR, INOGEN MINI ICD DR, DYNAGEN™ MINI ICD VR,DYNAGEN MINI ICD D
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S472
- Product code
- LWS
- Decision date
- 2021-10-21
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Automate a battery component cleaning process.
Current openFDA PMA Record#
- Device
- ORIGEN MINI ICD VR, ORIGEN MINI ICD DR, INOGEN™ MINI ICD VR, INOGEN MINI ICD DR, DYNAGEN™ MINI ICD VR,DYNAGEN MINI ICD D
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S472
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2021-10-21
- Decision code
- OK30
- Date received
- 2021-10-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Automate a battery component cleaning process.