The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Swift-lock Anchor.
| Device ID | K140272 |
| 510k Number | K140272 |
| Device Name: | SWIFT-LOCK ANCHOR |
| Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
| Applicant | ST. JUDE MEDICAL 6901 PRESTON ROAD Plano, TX 75024 |
| Contact | Diana Ortega |
| Correspondent | Diana Ortega ST. JUDE MEDICAL 6901 PRESTON ROAD Plano, TX 75024 |
| Product Code | GZB |
| CFR Regulation Number | 882.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-03 |
| Decision Date | 2014-05-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15415067016628 | K140272 | 000 |