PMA P010012S414
- Device
- Dynagen, Inogen, Origen Cardiac Resynchronization Therapy Defibrillators (CRT-Ds)
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S414
- Product code
- NIK
- Decision date
- 2016-04-14
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- Update work instructions for the manufacturing inspection process to define acceptable criteria for a cosmetic defect in high voltage capacitors.
Current openFDA PMA Record#
- Device
- Dynagen, Inogen, Origen Cardiac Resynchronization Therapy Defibrillators (CRT-Ds)
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S414
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2016-04-14
- Decision code
- OK30
- Date received
- 2016-03-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update work instructions for the manufacturing inspection process to define acceptable criteria for a cosmetic defect in high voltage capacitors.