PMA P060027S096
- Device
- Paradym CRT-D, Paradym RF CRT-D (ZL 102), Intensia CRT-D, Platinium CRT-D, Platinium 4LV CRT-D
- Applicant
- MicroPort CRM USA, Inc.
- PMA number
- P060027
- Supplement
- S096
- Product code
- NIK
- Decision date
- 2018-05-14
- 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 an alternate automated visual inspection for incoming inspection of die after dicing.
Current openFDA PMA Record#
- Device
- Paradym CRT-D, Paradym RF CRT-D (ZL 102), Intensia CRT-D, Platinium CRT-D, Platinium 4LV CRT-D
- Applicant
- MicroPort CRM USA, Inc.
- PMA number
- P060027
- Supplement
- S096
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2018-05-14
- Decision code
- OK30
- Date received
- 2018-04-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an alternate automated visual inspection for incoming inspection of die after dicing.