PARADYM IMPLANT SOFTWARE VERSION W2.8.4, AND ASSOCIATED PROGRAMMER SOFTWARE SMARTVIEW 2.22UG1
FDA premarket approval P060027/S026 · decided 2010-09-09
Approval details
- PMA number
- P060027
- Supplement
- S026
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PARADYM IMPLANT SOFTWARE VERSION W2.8.4, AND ASSOCIATED PROGRAMMER SOFTWARE SMARTVIEW 2.22UG1
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2010-06-28
- Decision date
- 2010-09-09
- Days to decision
- 73 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR REVISED EMBEDDED IMPLANT SOFTWARE (VERSION W2.8.4) AND REVISED SMARTVIEW PROGRAMMER SOFTWEAR (VERSION 2.22 UG2).
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