PMA P060027S099
- Device
- Cardiac Resynchronization Therapy Defibrillator
- Applicant
- MicroPort CRM USA, Inc.
- PMA number
- P060027
- Supplement
- S099
- Product code
- NIK
- Decision date
- 2019-03-05
- 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 pre-conditioning step prior to the Electrical Wafer Sorting test.
Current openFDA PMA Record#
- Device
- Cardiac Resynchronization Therapy Defibrillator
- Applicant
- MicroPort CRM USA, Inc.
- PMA number
- P060027
- Supplement
- S099
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2019-03-05
- Decision code
- OK30
- Date received
- 2019-02-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a pre-conditioning step prior to the Electrical Wafer Sorting test.