REPLY SR, REPLY DR, ESPIRIT SR, ESPIRIT DR
FDA premarket approval P950029/S088 · decided 2014-04-09
Approval details
- PMA number
- P950029
- Supplement
- S088
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- REPLY SR, REPLY DR, ESPIRIT SR, ESPIRIT DR
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2014-02-12
- Decision date
- 2014-04-09
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR MINOR DESIGN CHANGES TO THE SRAM AND ZENER DIODESFOR THE 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.