|
Device | EXOGEN 4000+ BONE HEALING SYSTEM |
Generic Name | Stimulator, ultrasound and muscle, for use other than applying therapeutic deep |
Applicant | BIOVENTUS LLC 4721 EMPEROR BLVD SUITE 100 DURHAM, NC 27703 |
PMA Number | P900009 |
Supplement Number | S030 |
Date Received | 12/23/2008 |
Decision Date | 03/13/2009 |
Product Code |
LPQ |
Advisory Committee |
Orthopedic |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR AN ALTERNATE SUPPLIER FOR THE MANUFACTURING OF THE PRINTED CIRCUIT BOARD ASSEMBLY (PCBA). |