PARADYM/PARADYM RF CRT-D
FDA premarket approval P060027/S048 · decided 2013-03-26
Approval details
- PMA number
- P060027
- Supplement
- S048
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PARADYM/PARADYM RF CRT-D
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2013-02-15
- Decision date
- 2013-03-26
- Days to decision
- 39 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR UPDATES TO THE ORCHESTRA/ORCHESTRA PLUS PROGRAMMER SOFTWARE APPLICATIONS THAT ARE USED TO INTERROGATE AND PROGRAM THE PARADYM AND PARADYM RF FAMILY OF ICDS AND CRT-D DEVICES.
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