ORCHESTRA PROGRAMMER
FDA premarket approval P980049/S013 · decided 2004-03-16
Approval details
- PMA number
- P980049
- Supplement
- S013
- 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
- 2004-02-20
- Decision date
- 2004-03-16
- Days to decision
- 25 days
- Decision code
- APPR
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR ELAVIEW 1.22 UG1 APPLICATION SOFTWARE FOR THE ORCHESTRA PROGRAMMER, RAM PATCH P2 FOR ALTO 2 ICD SYSTEM, RAM PATCH TI V5 FOR SYMPHONY AND ELA RHAPSODY PACEMAKERS, AND HSO 2.68 SOFTWARE AND V10+ HARDWARE FOR THE CPR3 PROGRAMMING HEAD.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.