Device Classification Name |
recorder, event, implantable cardiac, (without arrhythmia detection)
|
510(k) Number |
K163407 |
Device Name |
Confirm Rx Insertable Cardiac Monitor (ICM) System |
Applicant |
St. Jude Medical, Inc. |
15900 Valley View Ct. |
Sylmar,
CA
91342
|
|
Applicant Contact |
Jennifer Dunham |
Correspondent |
St. Jude Medical, Inc. |
15900 Valley View Ct. |
Sylmar,
CA
91342
|
|
Correspondent Contact |
Jennifer Dunham |
Regulation Number | 870.2800
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/05/2016 |
Decision Date | 09/29/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|