ELAVIEW 1.26 UG APPLICATION SOFTWARE FOR THE ORCHESTRA PROGRAMMER; RAM PATCHES ALTO P4 AND ALTO2 P3; AND HSO 2.70 SOFTWA
FDA premarket approval P980049/S017 · decided 2004-12-08
Approval details
- PMA number
- P980049
- Supplement
- S017
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ELAVIEW 1.26 UG APPLICATION SOFTWARE FOR THE ORCHESTRA PROGRAMMER; RAM PATCHES ALTO P4 AND ALTO2 P3; AND HSO 2.70 SOFTWA
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2004-09-15
- Decision date
- 2004-12-08
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR THE ELAVIEW 1.26 UG APPLICATION SOFTWARE FOR THE ORCHESTRA PROGRAMMER; RAM PATCHES ALTO P4 AND ALTO2 P3; AND HSO 2.70 SOFTWARE FOR THE CPR3 PROGRAMMING HEAD.
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