Reply SR and Reply DR Pacemakers
FDA premarket approval P950029/S125 · decided 2020-03-26
Approval details
- PMA number
- P950029
- Supplement
- S125
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Reply SR and Reply DR Pacemakers
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2020-02-27
- Decision date
- 2020-03-26
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- Implement automatic equipment for the interconnection electrical welding process used in pacemaker devices.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.