The following data is part of a premarket notification filed by Siemens-pacesetter, Inc. with the FDA for Cardiovascular Permanent Pacemaker Electrode.
| Device ID | K920822 |
| 510k Number | K920822 |
| Device Name: | CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE |
| Classification | Permanent Pacemaker Electrode |
| Applicant | SIEMENS-PACESETTER, INC. 15900 VALLEY VIEW COURT P.O.BOX 9221 Sylmar, CA 91392 -9221 |
| Contact | Glenn Thompson |
| Correspondent | Glenn Thompson SIEMENS-PACESETTER, INC. 15900 VALLEY VIEW COURT P.O.BOX 9221 Sylmar, CA 91392 -9221 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Se - Postmarket Surveillance Required (SESP) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-24 |
| Decision Date | 1993-01-22 |