The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Paceart Optima System Software.
| Device ID | K110693 |
| 510k Number | K110693 |
| Device Name: | PACEART OPTIMA SYSTEM SOFTWARE |
| Classification | Analyzer, Pacemaker Generator Function, Indirect |
| Applicant | MEDTRONIC, INC. 8200 CORAL SEA STREET Mounds View, MN 55304 |
| Contact | Rachel U Libi |
| Correspondent | Rachel U Libi MEDTRONIC, INC. 8200 CORAL SEA STREET Mounds View, MN 55304 |
| Product Code | KRE |
| Subsequent Product Code | DPS |
| Subsequent Product Code | DXH |
| Subsequent Product Code | OUG |
| CFR Regulation Number | 870.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-11 |
| Decision Date | 2011-06-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169956810 | K110693 | 000 |
| 00643169956803 | K110693 | 000 |
| 00643169876927 | K110693 | 000 |
| 00643169707351 | K110693 | 000 |
| 00643169552296 | K110693 | 000 |
| 00643169463523 | K110693 | 000 |
| 00643169411296 | K110693 | 000 |
| 00643169345058 | K110693 | 000 |
| 00763000083342 | K110693 | 000 |