|
Device | ENRHYTHM IPG |
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 | S045 |
Date Received | 07/26/2005 |
Decision Date | 09/30/2005 |
Product Code |
NVZ |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO VERIFY ADDITIONAL PROGRAMMING PARAMETERS AT THE POST-STERILIZATION MANUFACTURING STEP. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES ENTRUST IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND ENRHYTHM IMPLANTABLE PULSE GENERATOR RESPECTIVELY. |