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. |
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Device | PASSIVE FIXATION FAMILY OF LEADS |
Generic Name | Pulse generator, permanent, implantable |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P880086 |
Supplement Number | S154 |
Date Received | 09/28/2007 |
Decision Date | 10/31/2007 |
Product Code |
NVZ |
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 CHANGE IN THE MANUFACTURING ENVIRONMENT FROM A CLASS 10,000 CLEAN ROOM TO A CLASS 100,000 CLEAN ROOM FOR THE ASSEMBLY OF THE LOW-VOLTAGE AND LEFT VENTRICULAR FAMILIES OF LEADS. |
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