PARADYM VR ICD, DR ICD, RF VR ICD, RD DR ICD, ORCHESTRA AND ORCHESTRA PLUS PROGRAMMERS
FDA premarket approval P980049/S097 · decided 2014-06-27
Approval details
- PMA number
- P980049
- Supplement
- S097
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PARADYM VR ICD, DR ICD, RF VR ICD, RD DR ICD, ORCHESTRA AND ORCHESTRA PLUS PROGRAMMERS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2014-04-23
- Decision date
- 2014-06-27
- Days to decision
- 65 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR EMBEDDED SOFTWARE CHANGES FOR THE DEVICES AND A REVISION TO THE ORCHESTRA/ORCHESTRA PLUS SOFTWARE PROGRAMMING MODULE.
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