ORCHESTRA PROGRAMMER
FDA premarket approval P980049/S002 · decided 2000-11-13
Approval details
- PMA number
- P980049
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ORCHESTRA PROGRAMMER
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2000-07-06
- Decision date
- 2000-11-13
- Days to decision
- 130 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR ORCHESTRA PROGRAMMER WITH THE FOLLOWING APPLICATION SOFTWARE PACKAGES: MANAGER SOFTWARE APPLICATION VERSION 1.02, CSO A PROGRAMMER APPLICATION VERSION 2.21, CSO-WINDOWS PROGRAMMER APPLICATION VERSION 1.03, DEFENDER II PROGRAMMER APPLICATION VERSION 2.03, AND DEFENDER IV PROGRAMMER APPLICATION VERSION 1.03.
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