|
Device | INSYNC PULSE GENERATOR; INSYNC III |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P010015 |
Supplement Number | S051 |
Date Received | 08/11/2008 |
Decision Date | 09/10/2008 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement ADDITION FO AN ETO STERILIZER AT THE TOLOCHENAZ, SWITZERLAND FACILITY AND CHANGES TO THE ETHYLENE OXIDE STERILIZATION LETHALITY MODEL. THE ADDITION OF THE ETO STERILIZER IS NOT APPLICABLE TO THE FOLLOWING DEVICES: CONSULTA, MAXIMO II, SECURA DR/VR FAMILY, AND MAXIMO II DDR/VR FAMILY. |
Post-Approval Study | Show Report Schedule and Study Progress |