PMA P960040S424
- Device
- NG2.5 (Dynagen Mini/Inogen Mini/ Origen Mini), Pervica ICD Pulse Generator
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S424
- Product code
- LWS
- Decision date
- 2018-04-10
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Additional facility for manufacturing battery case halves.
Current openFDA PMA Record#
- Device
- NG2.5 (Dynagen Mini/Inogen Mini/ Origen Mini), Pervica ICD Pulse Generator
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S424
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2018-04-10
- Decision code
- OK30
- Date received
- 2018-04-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional facility for manufacturing battery case halves.