|
Device | GEN 2 S-ICD & SQ-RX PULSE GENERATOR, SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFRILLATOR |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC CORPORATION 4100 HAMLINE AVENUE NORTH ST. PAUL, MN 55112-5798 |
PMA Number | P110042 |
Supplement Number | S052 |
Date Received | 09/30/2015 |
Decision Date | 10/21/2015 |
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 ELIMINATE AN EQUIPMENT CHECK PERFORMED ON EQUIPMENT USED TO TEST PARYLENE COATING THICKNESS OF BATTERIES AND CAPACITORS USED IN THE DEVICE MODELS. |