|
Device | ATTAIN BIPOLAR OTW LEAD , LEAD VENTRICULAR PACING LEAD |
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 | S226 |
Date Received | 10/30/2013 |
Decision Date | 11/26/2013 |
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 | Yes |
Recalls | CDRH Recalls |
Approval Order Statement REDUCE THE EXPOSURE TIME DURING ETHYLENE-OXIDE HALF-CYCLE TESTING. |
Post-Approval Study | Show Report Schedule and Study Progress |