Reply SR, Reply DR
FDA premarket approval P950029/S131 · decided 2021-03-10
Approval details
- PMA number
- P950029
- Supplement
- S131
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Reply SR, Reply DR
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2021-02-09
- Decision date
- 2021-03-10
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- Update the in-process treatment of the pacemaker headers and the final cleaning process for pacemakers and their screwdriver accessory.
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