BIO OSTEOGEN SYSTEM 204
FDA premarket approval P790002/S035 · decided 2016-03-07
Approval details
- PMA number
- P790002
- Supplement
- S035
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BIO OSTEOGEN SYSTEM 204
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 2016-02-11
- Decision date
- 2016-03-07
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- Qualify and approve an alternate supplier to perform the coil covering/sewing manufacturing process and for fabricating an optional accessory extremity band.
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