STELIX II EASY TURN LEAD MODELS BRF24D, BRF25D, BRF26D
FDA premarket approval P020030/S003 · decided 2006-07-12
Approval details
- PMA number
- P020030
- Supplement
- S003
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- STELIX II EASY TURN LEAD MODELS BRF24D, BRF25D, BRF26D
- Generic name
- Permanent defibrillator electrodes
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2006-05-25
- Decision date
- 2006-07-12
- Days to decision
- 48 days
- Decision code
- APPR
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR MODIFICATIONS TO THE HELIX MECHANISM, ADDITION OF RADIOPAQUE MARKERS, AND MODIFICATIONS TO THE DEVICE INSPECTION PROCEDURES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME STELIX II EASY TURN MODELS BRF24D, BRF25D, AND BRF26D AND ARE DESIGNED TO BE USED WITH AN IMPLANTABLE PACEMAKER FOR PACING AND SENSING OF THE HEART.
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