PMA P010012S509
- Device
- Origen, Inogen, Dynagen, Autogen, Momentum, Vigilant, and Resonate Cardiac Resynchronization Therapy Defibrillator (CRT-
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S509
- Product code
- NIK
- Decision date
- 2019-09-24
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- Change the degreaser solvent used in the vapor degreaser process.
Current openFDA PMA Record#
- Device
- Origen, Inogen, Dynagen, Autogen, Momentum, Vigilant, and Resonate Cardiac Resynchronization Therapy Defibrillator (CRT-
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S509
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2019-09-24
- Decision code
- OK30
- Date received
- 2019-09-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change the degreaser solvent used in the vapor degreaser process.