The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Psa Cable.
| Device ID | K170815 |
| 510k Number | K170815 |
| Device Name: | PSA Cable |
| Classification | Analyzer, Pacemaker Generator Function |
| Applicant | Boston Scientific Corporation 4100 Hamline Ave North St. Paul, MN 55112 |
| Contact | Melissa Klamerus |
| Correspondent | Melissa Klamerus Boston Scientific Corporation 4100 Hamline Ave North St. Paul, MN 55112 |
| Product Code | DTC |
| CFR Regulation Number | 870.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-17 |
| Decision Date | 2017-07-06 |
| Summary: | summary |