PMA P010012S449
- Device
- Cardiac Resynchronization Therapy Defibrillator (CRT-D) ORIGEN, INOGEN, DYNAGEN, AUTOGEN, PUNCTUA, ENERGEN, INCEPTA, MOM
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S449
- Product code
- NIK
- Decision date
- 2017-06-06
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- Alternate supplier for Titanium ribbon.
Current openFDA PMA Record#
- Device
- Cardiac Resynchronization Therapy Defibrillator (CRT-D) ORIGEN, INOGEN, DYNAGEN, AUTOGEN, PUNCTUA, ENERGEN, INCEPTA, MOM
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S449
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2017-06-06
- Decision code
- OK30
- Date received
- 2017-05-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate supplier for Titanium ribbon.