ORTHOPAK II BONE GROWTH STIMULATOR
FDA premarket approval P850022/S011 · decided 1998-07-14
Approval details
- PMA number
- P850022
- Supplement
- S011
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ORTHOPAK II BONE GROWTH STIMULATOR
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 1998-06-18
- Decision date
- 1998-07-14
- Days to decision
- 26 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- Approval for the following modifications:1)The "tombstone" - No part Number a)Change of indication b)Minor grammatical corrections of labeling 2)The Physician Manual-Part Number 380-0001-0001-844 a)Change of indication b)Removed all references to "Snap-on Electrodes" (obsolete) c)Reduced the number of sizes of foam spacers provided from two to one d)Increased the number of leads provided from two to three (20" lead added) e)Minor grammatical corrections of labeling 3)The Patient Manual - Part Nu
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