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 | ENRHYTHM P1501 DR |
Generic Name | Pulse generator, permanent, implantable |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P980035 |
Supplement Number | S081 |
Date Received | 11/16/2007 |
Decision Date | 12/04/2007 |
Product Code |
NVZ |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MINOR DESIGN CHANGES THAT ADD TWO ALTERNATE TANTALUM CAPACITORS (XTC017, XTC018) WITH INCREASED VOLTAGE RATINGS TO APPROVED DEVICE COMPONENTS. THE DESIGN MODIFICATIONS ARE INTENDED TO REDUCE MANUFACTURING YIELD LOSS AND ASSOCIATED REWORK. |
|
|