PMA P010012S468
- Device
- Autogen, Dynagen, Inogen, Origen (NG3 CRT-Ds), Momentum, Resonate, Vigilant (NG4 CRT-Ds)
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S468
- Product code
- NIK
- Decision date
- 2017-12-01
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- Upgrade device header overmolding equipment.
Current openFDA PMA Record#
- Device
- Autogen, Dynagen, Inogen, Origen (NG3 CRT-Ds), Momentum, Resonate, Vigilant (NG4 CRT-Ds)
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S468
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2017-12-01
- Decision code
- OK30
- Date received
- 2017-11-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Upgrade device header overmolding equipment.