PMA P060027S092
- Device
- Cardiac Resynchronization Therapy Defibrillator CRT-Ds
- Applicant
- MicroPort CRM USA, Inc.
- PMA number
- P060027
- Supplement
- S092
- Product code
- NIK
- Decision date
- 2018-01-25
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- Replace the solder mask material, to allow for rework of RF modules on hybrids, and to incorporate use of alternate thermosealing equipment during the packaging process.
Current openFDA PMA Record#
- Device
- Cardiac Resynchronization Therapy Defibrillator CRT-Ds
- Applicant
- MicroPort CRM USA, Inc.
- PMA number
- P060027
- Supplement
- S092
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2018-01-25
- Decision code
- OK30
- Date received
- 2018-01-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replace the solder mask material, to allow for rework of RF modules on hybrids, and to incorporate use of alternate thermosealing equipment during the packaging process.