PMA P060027S095
- Device
- Paradym RF CRT-d 9750, Platinium CRT-D 1711, Platinium CRT-D 1741, Platinium 4 LV CRT-D 1744
- Applicant
- MicroPort CRM USA, Inc.
- PMA number
- P060027
- Supplement
- S095
- Product code
- NIK
- Decision date
- 2018-04-25
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- Minor sterilization cycle and sterilization equipment changes.
Current openFDA PMA Record#
- Device
- Paradym RF CRT-d 9750, Platinium CRT-D 1711, Platinium CRT-D 1741, Platinium 4 LV CRT-D 1744
- Applicant
- MicroPort CRM USA, Inc.
- PMA number
- P060027
- Supplement
- S095
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2018-04-25
- Decision code
- OK30
- Date received
- 2018-03-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Minor sterilization cycle and sterilization equipment changes.