PMA P060027S100
- Device
- Platinium 4LV CRT-D
- Applicant
- MicroPort CRM USA, Inc.
- PMA number
- P060027
- Supplement
- S100
- Product code
- NIK
- Decision date
- 2019-12-04
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- Modification of the insert block machining process.
Current openFDA PMA Record#
- Device
- Platinium 4LV CRT-D
- Applicant
- MicroPort CRM USA, Inc.
- PMA number
- P060027
- Supplement
- S100
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2019-12-04
- Decision code
- OK30
- Date received
- 2019-11-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modification of the insert block machining process.