PMA P010012S432
- Device
- ORIGEN; INOGEN; DYNAGEN; PUNCTUA; ENERGEN; INCEPTA CRT-Ds
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S432
- Product code
- NIK
- Decision date
- 2016-09-29
- 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 software interface between the traceability system software and the braze oven equipment for the feedthru component braze process.
Current openFDA PMA Record#
- Device
- ORIGEN; INOGEN; DYNAGEN; PUNCTUA; ENERGEN; INCEPTA CRT-Ds
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S432
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2016-09-29
- Decision code
- OK30
- Date received
- 2016-09-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a software interface between the traceability system software and the braze oven equipment for the feedthru component braze process.