REPLY/ESPRIT PACEMAKERS
FDA premarket approval P950029/S086 · decided 2014-03-18
Approval details
- PMA number
- P950029
- Supplement
- S086
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- REPLY/ESPRIT PACEMAKERS
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2014-01-10
- Decision date
- 2014-03-18
- Days to decision
- 67 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR UPDATED ORCHESTRA/ORCHESTRA PLUS PROGRAMMERSOFTWARE, REPLY 1.16 AND PACEART 1.12.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.