PMA P950029S131
- Device
- Reply SR, Reply DR
- Applicant
- MicroPort CRM USA, Inc.
- PMA number
- P950029
- Supplement
- S131
- Product code
- DXY
- Decision date
- 2021-03-10
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- Update the in-process treatment of the pacemaker headers and the final cleaning process for pacemakers and their screwdriver accessory.
Current openFDA PMA Record#
- Device
- Reply SR, Reply DR
- Applicant
- MicroPort CRM USA, Inc.
- PMA number
- P950029
- Supplement
- S131
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2021-03-10
- Decision code
- OK30
- Date received
- 2021-02-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update the in-process treatment of the pacemaker headers and the final cleaning process for pacemakers and their screwdriver accessory.