PMA P010012S479
- Device
- NG3 Cardiac Resynchronization Therapy Defibrillators - Origen, Inogen, Dynagen, Autogen / NG4 Cardiac Resynchronization
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S479
- Product code
- NIK
- Decision date
- 2018-02-21
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- Modify the taping process for capacitors by adding a new equipment.
Current openFDA PMA Record#
- Device
- NG3 Cardiac Resynchronization Therapy Defibrillators - Origen, Inogen, Dynagen, Autogen / NG4 Cardiac Resynchronization
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S479
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2018-02-21
- Decision code
- OK30
- Date received
- 2018-02-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modify the taping process for capacitors by adding a new equipment.