Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | INCEPTA, ENERGEN,PUNCTUA, DYNAGEN, INOGEN, ORIGEN ICD'S |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960040 |
Supplement Number | S352 |
Date Received | 07/13/2015 |
Decision Date | 08/08/2015 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ADD AN ADDITIONAL INSPECTION STEP TO PULSE GENERATOR CASE HALF MANUFACTURING, ALONG WITH ASSOCIATED SPECIFICATION AND INSPECTION CRITERIA, THAT WILL ALLOW PULSE GENERATOR CASE HALF DISCONTINUITIES TO BE DISTINGUISHED FROM DENTS. |
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