The following data is part of a premarket notification filed by Tyrx Pharma, Inc. with the FDA for Pivit Crm (tyrx Antimicrobial Pacemaker Pouch), Model Cmrm-0601.
| Device ID | K063091 |
| 510k Number | K063091 |
| Device Name: | PIVIT CRM (TYRX ANTIMICROBIAL PACEMAKER POUCH), MODEL CMRM-0601 |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | TYRX PHARMA, INC. 1 DEER PARK DR. SUITE G Monmouth Junction, NJ 08852 |
| Contact | Mason W Diamond |
| Correspondent | Mason W Diamond TYRX PHARMA, INC. 1 DEER PARK DR. SUITE G Monmouth Junction, NJ 08852 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2006-10-10 |
| Decision Date | 2008-01-16 |
| Summary: | summary |