ORTHOPAK 2 BONE GROWTH STIMULATOR SYSTEM
FDA premarket approval P850022/S016 · decided 2006-07-27
Approval details
- PMA number
- P850022
- Supplement
- S016
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ORTHOPAK 2 BONE GROWTH STIMULATOR SYSTEM
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 2006-02-06
- Decision date
- 2006-07-27
- Days to decision
- 171 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- APPROVAL FOR THE FOLLOWING DEVICE MODIFICATIONS: 1) THE STIMULATOR HAS BEEN MODIFIED TO INCLUDE: A) A NEW USER INTERFACE (SIMILAR TO P850022/S015). THE USER INTERFACE INCLUDES AN ALARM BUTTON, YELLOW LED, AND A LCD DISPLAY TO INDICATE TREATING STATUS; B) AN AUDIBLE AND VISIBLE SELF-CHECKING ALARM MECHANISM WITH ADDITIONAL MALFUNCTION SOURCE INDICATORS (SAME AS P850022/S015). THE AUDIBLE ALARM MECHANISM CAN BE DISABLED USING THE ALARM BUTTON; C) A NEW MAIN PCB CIRCUIT BOARD (SAME AS P850022/S015)
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