ORTHOGEN/OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATOR
FDA premarket approval P790005/S047 · decided 2011-05-06
Approval details
- PMA number
- P790005
- Supplement
- S047
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ORTHOGEN/OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATOR
- Generic name
- Stimulator, invasive bone growth
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 2011-04-08
- Decision date
- 2011-05-06
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- LOE
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- APPROVAL FOR MANUFACTURING CHANGES INVOLVING THE VERIFICATION OF ALCOHOL STERILITY AND THE MAGNET OVERRIDING TEST FIXTURE.
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