OSTEOSTIM(TM) IMPLANTABLE BONE GROWTH STIMULATOR
FDA premarket approval P790005/S032 · decided 1988-04-21
Approval details
- PMA number
- P790005
- Supplement
- S032
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- OSTEOSTIM(TM) IMPLANTABLE BONE GROWTH STIMULATOR
- Generic name
- Stimulator, invasive bone growth
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 1988-03-16
- Decision date
- 1988-04-21
- Days to decision
- 36 days
- Decision code
- APPR
- Product code
- LOE
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
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