PMA P010012S431
- Device
- NG3 Cardiac Resynchronization Therapy-Defibrillator (CRT); DYNAGEN. INOGEN, ORIGEN CRT-D & X4 CRT-D
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S431
- Product code
- NIK
- Decision date
- 2016-09-13
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- Changes to visual inspection criteria for cosmetic defects.
Current openFDA PMA Record#
- Device
- NG3 Cardiac Resynchronization Therapy-Defibrillator (CRT); DYNAGEN. INOGEN, ORIGEN CRT-D & X4 CRT-D
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S431
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2016-09-13
- Decision code
- OK30
- Date received
- 2016-08-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to visual inspection criteria for cosmetic defects.