PMA P010012S454
- Device
- Autogen, Dynagen, Inogen, Origen NG3 CRT-Ds; Resonate, Vigilant, NG4 CRT-Ds; Acuity , Slit Suture Sleeve Accessory for A
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S454
- Product code
- NIK
- Decision date
- 2017-07-25
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Current openFDA PMA Record#
- Device
- Autogen, Dynagen, Inogen, Origen NG3 CRT-Ds; Resonate, Vigilant, NG4 CRT-Ds; Acuity , Slit Suture Sleeve Accessory for A
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S454
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2017-07-25
- Decision code
- APPR
- Date received
- 2017-05-31
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB