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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceBIOLECTRON ORTHOPAK BONE GROWTH STIMULAOR & BIOLECTRON SPINALPAK FUSION STIMULATOR
Generic NameStimulator, bone growth, non-invasive
Regulation Number890.5870
ApplicantAhp Eos Buyer, Inc.
1 Gatehall Dr.
Suite 303
Parsippany, NJ 07054
PMA NumberP850022
Supplement NumberS013
Date Received06/11/2001
Decision Date10/10/2001
Reclassified Date05/18/2026
Product Code LOF 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY LOCATED AT ELECTRO-BIOLOGY, INC., GUAYNABO, PUERTO RICO.
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