PARADYM VR/DR, PARADYM RF VR/RF DR
FDA premarket approval P980049/S094 · decided 2014-04-17
Approval details
- PMA number
- P980049
- Supplement
- S094
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PARADYM VR/DR, PARADYM RF VR/RF DR
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2014-03-18
- Decision date
- 2014-04-17
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR DESIGN CHANGES TO THE SETSCREWS AND TORQUE SCREWDRIVER USED IN CONNECTING THE LEADS TO IMPLANTABLE DEFIBRILLATORS.
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