|
Device | RESTOREPRIME & PRIMEADVANCED IMPLANTABLE NEUROSTIMULATORS |
Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
Applicant | MEDTRONIC NEUROMODULATION 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432 |
PMA Number | P840001 |
Supplement Number | S144 |
Date Received | 12/23/2009 |
Decision Date | 01/21/2010 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement INCREASE IN THE PRESS FORCE USED TO FORM THE BATTERY CATHODES WHICH WILL REDUCE THE CATHODE THICKNESS VARIATION AND INCREASE THE YIELD OF THE RX1 BATTERY PRODUCTION. |