PMA P060027S097
- Device
- CRT-Ds (Cardiac Resynchronization Therapy Defibrillator) Platinium
- Applicant
- MicroPort CRM USA, Inc.
- PMA number
- P060027
- Supplement
- S097
- Product code
- NIK
- Decision date
- 2018-12-06
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- Add equipment used for solder past printing during electronic assembly and add a rework process used for component replacement.
Current openFDA PMA Record#
- Device
- CRT-Ds (Cardiac Resynchronization Therapy Defibrillator) Platinium
- Applicant
- MicroPort CRM USA, Inc.
- PMA number
- P060027
- Supplement
- S097
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2018-12-06
- Decision code
- OK30
- Date received
- 2018-11-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add equipment used for solder past printing during electronic assembly and add a rework process used for component replacement.