STELIX/STELIX II STEROID ELUTING PACING LEADS; EASYTURN/EASYTURN ACCESSORY SYTLET KITS
FDA premarket approval P020030/S001 · decided 2004-11-22
Approval details
- PMA number
- P020030
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- STELIX/STELIX II STEROID ELUTING PACING LEADS; EASYTURN/EASYTURN ACCESSORY SYTLET KITS
- Generic name
- Permanent defibrillator electrodes
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2004-07-16
- Decision date
- 2004-11-22
- Days to decision
- 129 days
- Decision code
- APPR
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR THE INTRODUCTION OF THE EASYTURN DEPLOYMENT MECHANISM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME STELIX II EASYTURN AND IS INDICTED FOR USE WITH AN IMPLANTABLE PACEMAKER. THEY ARE INTENDED FOR PERMANENT PACING AND SENSING OF THE ATRIUM.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.