REPLY/ESPRIT PACEMAKER IMPLANTABLE DEVICES
FDA premarket approval P980049/S118 · decided 2016-10-04
Approval details
- PMA number
- P980049
- Supplement
- S118
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- REPLY/ESPRIT PACEMAKER IMPLANTABLE DEVICES
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2016-07-26
- Decision date
- 2016-10-04
- Days to decision
- 70 days
- Decision code
- APPR
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- Approval for version 1.20 of the Orchestra & Orchestra Plus Programmer software used to interrogate and program the Reply/Esprit pacemakers.
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