BIO OSTEOGEN SYSTEM
FDA premarket approval P790002/S027 · decided 2011-09-07
Approval details
- PMA number
- P790002
- Supplement
- S027
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BIO OSTEOGEN SYSTEM
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 2011-08-11
- Decision date
- 2011-09-07
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- REPLACEMENT OF AN ANALOG ELECTRICAL ISOLATION TESTER WITH A DIGITAL ELECTRONIC ISOLATION TESTER, AND ADDITION OF A MANUAL HAND-SOLDERING PROCESS AS AN ALTERNATIVE TO THE EXISTING AUTOMATIC SOLDERING PROCESS.
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