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 | CONTAK RENEWAL 3 CRT-DS, CONTAK RENEWAL 3 HE CRT-DS, LIVIAN CRT-DS, PUNCTUA CRT-DS |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | Boston Scientific Corp. 4100 HAMLINE AVE NORTH ST. PAUL, MN 55112 |
PMA Number | P010012 |
Supplement Number | S307 |
Date Received | 10/01/2012 |
Decision Date | 11/07/2012 |
Product Code |
LWP |
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 ADDITIONAL PROCESS INSPECTION EQUIPMENT WITH SOFTWARE AND FIXTURE MODIFICATIONS. |
|
|