The following data is part of a premarket notification filed by St Jude Medical, Crmd with the FDA for Merlin Psa Patient Cable Ex 3150, Cable Adapter Ex3170, M Adapter Ex3180.
| Device ID | K101982 |
| 510k Number | K101982 |
| Device Name: | MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180 |
| Classification | Tester, Pacemaker Electrode Function |
| Applicant | ST JUDE MEDICAL, CRMD 701 E. EVELYN AVENUE Sunnyvale, CA 94086 |
| Contact | Gina Correa |
| Correspondent | Gina Correa ST JUDE MEDICAL, CRMD 701 E. EVELYN AVENUE Sunnyvale, CA 94086 |
| Product Code | DTA |
| CFR Regulation Number | 870.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-14 |
| Decision Date | 2010-12-21 |
| Summary: | summary |