Reply SR, Reply DR, Esprit SR, Esprit DR
FDA premarket approval P950029/S122 · decided 2018-05-14
Approval details
- PMA number
- P950029
- Supplement
- S122
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Reply SR, Reply DR, Esprit SR, Esprit DR
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2018-04-19
- Decision date
- 2018-05-14
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- Addition of an alternate automated visual inspection for incoming inspection of die after dicing.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.