PMA P960040S372
- Device
- NG3 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR(ICD). ORIGEN , INOGEN, DYNAGEN EL ICD'S. NG2.5 IMPLANTABLE CARDIOVERTER DEFIB
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S372
- Product code
- LWS
- Decision date
- 2016-05-25
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Addition of a new acrylic dispense system in the pulse generator header manufacturing process.
Current openFDA PMA Record#
- Device
- NG3 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR(ICD). ORIGEN , INOGEN, DYNAGEN EL ICD'S. NG2.5 IMPLANTABLE CARDIOVERTER DEFIB
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S372
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2016-05-25
- Decision code
- OK30
- Date received
- 2016-05-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a new acrylic dispense system in the pulse generator header manufacturing process.