ORCHESTRA AND ORCHESTRA PLUS PROGRAMMER
FDA premarket approval P980049/S109 · decided 2016-06-24
Approval details
- PMA number
- P980049
- Supplement
- S109
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ORCHESTRA AND ORCHESTRA PLUS PROGRAMMER
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2015-03-30
- Decision date
- 2016-06-24
- Days to decision
- 452 days
- Decision code
- APPR
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- Approval for hardware modifications to the REPLY / ESPRIT pacemaker platform.
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