PMA P010012S507
- Device
- Momentum, Resonate, Autogen, and Dynagen (CRT-D)
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S507
- Product code
- NIK
- Decision date
- 2019-07-18
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- Move optional rework steps to the standard assembly process for LV-1 pulse generators.
Current openFDA PMA Record#
- Device
- Momentum, Resonate, Autogen, and Dynagen (CRT-D)
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S507
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2019-07-18
- Decision code
- OK30
- Date received
- 2019-07-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Move optional rework steps to the standard assembly process for LV-1 pulse generators.