STARFLEX SEPTAL OCCLUSION SYSTEM
FDA premarket approval P000049/S016 · decided 2009-03-05
Approval details
- PMA number
- P000049
- Supplement
- S016
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- STARFLEX SEPTAL OCCLUSION SYSTEM
- Generic name
- Transcatheter septal occluder
- Applicant
- Nmt Medical, Inc.
- Date received
- 2006-03-02
- Decision date
- 2009-03-05
- Days to decision
- 1099 days
- Decision code
- APPR
- Product code
- MLV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Boston, MA
- Statement
- APPROVAL FOR THE ADDITION OF THE STARFLEX VSD OCCLUDER IN THREE SIZES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME STARFLEX SEPTAL OCCLUDER AND IS INDICATED FOR USE IN PATIENTS WITH A COMPLEX VENTRICULAR SEPTAL DEFECT (VSD) OF A SIGNIFICANT SIZE TO WARRANT CLOSURE, BUT THAT BASED ON LOCATION, CANNOT BE CLOSED WITH STANDARD TRANSATRIAL OR TRANSARTERIAL APPROACHES.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC (K034025) | Nmt Medical, Inc. | 2004-03-26 |
| SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754T (K994191) | Nmt Medical, Inc. | 2000-02-08 |