CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD
FDA premarket approval P000049 · decided 2001-12-05
Approval details
- PMA number
- P000049
- Trade name
- CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD
- Generic name
- Transcatheter septal occluder
- Applicant
- Nmt Medical, Inc.
- Date received
- 2000-11-21
- Decision date
- 2001-12-05
- Days to decision
- 379 days
- Decision code
- APPR
- Product code
- MLV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Boston, MA
- Statement
- APPROVAL FOR THE CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD. THE SYSTEM IS INDICATED FOR USE IN PATIENTS WITH COMPLEX VENTRICULAR SEPTAL DEFECTS (VSD) OF SIGNIFICANT SIZE TO WARRANT CLOSURE WHO ARE CONSIDERED TO BE AT HIGH RISK FOR STANDARD TRANSATRIAL OR TRANSARTERIAL SURGICAL CLOSURE BASED ON ANATOMICAL CONDITIONS AND/OR BASED ON OVERALL MEDICAL CONDITION. HIGH RISK ANATOMICAL FACTORS FOR TRANSATRIAL OR TRANSARTERIAL SURGICAL CLOSURE INCLUDE PATIENTS: 1) REQUIRING A LEFT VENTRICULOTOMY O
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |