|
Device | SPF IMPLANTABLE BONE GROWTH STIMULATOR |
Generic Name | Stimulator, invasive bone growth |
Applicant | EBI, LLC 1 Gatehall Drive Suite 303 Parsippany, NJ 07054 |
PMA Number | P850035 |
Supplement Number | S025 |
Date Received | 03/31/2000 |
Decision Date | 09/27/2000 |
Product Code |
LOE |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR REVISED LABELING BASED ON THE FINDINGS OF THE POST-APPROVAL STUDY FOR THE SPF(R) IMPLANTABLE BONE GROWTH STIMULATOR. |