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. |
|
Device | ORIGEN™ MINI ICD VR, ORIGEN™ MINI ICD DR, INOGEN™ MINI ICD VR, INOGEN™ MINI ICD DR, DYNAGEN™ MINI ICD VR, DYNAGEN™ MINI |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960040 |
Supplement Number | S474 |
Date Received | 12/16/2021 |
Decision Date | 12/21/2021 |
Product Code |
LWS |
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 alternate nitrile gloves to be used in the manufacturing operations at BSC-Clonmel. |
|
|