ORCHESTRA PROGRAMMER
FDA premarket approval P980049/S010 · decided 2003-10-14
Approval details
- PMA number
- P980049
- Supplement
- S010
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ORCHESTRA PROGRAMMER
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2003-09-11
- Decision date
- 2003-10-14
- Days to decision
- 33 days
- Decision code
- APPR
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR MODIFICATIONS TO THE PROGRAMMING HEAD OF THE ORCHESTRA PROGRAMMER, INCLUDING THE ADDITION OF HIGH-SPEED TELEMETRY AND OTHER CHANGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CPR3 PROGRAMMING HEAD AND IS INDICATED FOR USE WITH THE ORCHESTRA DEDICATED PROGRAMMER TO INTERROGATE AND PROGRAM ELA MEDICAL PULSE GENERATORS VIA BI-DIRECTIONAL TELEMETRY.
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