The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Atrium Medical Corporation Advanta Ptfe Facial Implant.
| Device ID | K992991 |
| 510k Number | K992991 |
| Device Name: | ATRIUM MEDICAL CORPORATION ADVANTA PTFE FACIAL IMPLANT |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson, NH 03051 |
| Contact | Karen Hall |
| Correspondent | Karen Hall ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson, NH 03051 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-07 |
| Decision Date | 2000-01-27 |