Device Classification Name |
analyzer, pacemaker generator function
|
510(k) Number |
K170815 |
Device Name |
PSA Cable |
Applicant |
Boston Scientific Corporation |
4100 Hamline Ave North |
St. Paul,
MN
55112
|
|
Applicant Contact |
Melissa Klamerus |
Correspondent |
Boston Scientific Corporation |
4100 Hamline Ave North |
St. Paul,
MN
55112
|
|
Correspondent Contact |
Melissa Klamerus |
Regulation Number | 870.3630
|
Classification Product Code |
|
Date Received | 03/17/2017 |
Decision Date | 07/06/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|