CARDIOSEAL SEPTAL OCCLUSION SYSTEM
FDA premarket approval P000049/S013 · decided 2004-05-14
Approval details
- PMA number
- P000049
- Supplement
- S013
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CARDIOSEAL SEPTAL OCCLUSION SYSTEM
- Generic name
- Transcatheter septal occluder
- Applicant
- Nmt Medical, Inc.
- Date received
- 2004-04-16
- Decision date
- 2004-05-14
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MLV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Boston, MA
- Statement
- CHANGE IN THE MANUFACTURING PROCESS TO PROPOSE AN ALTERNATE VENDOR FOR THE DEVICE.
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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 |