|
Device | SPRINT QUATTRO LEAD, SUBCUTANEOUS LEAD, TRANSVENE CS/SVC LEAD |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P920015 |
Supplement Number | S121 |
Date Received | 10/24/2013 |
Decision Date | 11/19/2013 |
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 | Yes |
Approval Order Statement REMOVE THE ANNUAL REQUIREMENT FOR ETHYLENE OXIDE RESIDUAL TESTING AT MEDTRONIC FINAL DEVICE MANUFACTURING FACILITIES. |