|
Device | CONSULTA AND SYNCRA CRT-P'S |
Generic Name | Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P010015 |
Supplement Number | S210 |
Date Received | 07/17/2013 |
Decision Date | 08/12/2013 |
Product Code |
NKE |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement CHANGE FOR AN INCOMING MATERIAL ACCEPTANCE PROCEDURE FOR UNDERFILL CURE EPOXY. |
Post-Approval Study | Show Report Schedule and Study Progress |