PMA P010012S495
- Device
- Cardiac Resynchronization Therapy Defibrillators (CRT-D) Origen, Inogen, Dynagen, Autogen and Momentum CRT-D
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S495
- Product code
- NIK
- Decision date
- 2019-01-23
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- Addition of a second supplier for the Hydrogen Getter Sheet Material and a process change to increase the lot size.
Current openFDA PMA Record#
- Device
- Cardiac Resynchronization Therapy Defibrillators (CRT-D) Origen, Inogen, Dynagen, Autogen and Momentum CRT-D
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S495
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2019-01-23
- Decision code
- OK30
- Date received
- 2018-12-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a second supplier for the Hydrogen Getter Sheet Material and a process change to increase the lot size.