ORTHOGEN/OSTEOGEN IMPLANT. BONE GROWTH STIMULATOR
FDA premarket approval P790005/S037 · decided 1995-04-06
Approval details
- PMA number
- P790005
- Supplement
- S037
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ORTHOGEN/OSTEOGEN IMPLANT. BONE GROWTH STIMULATOR
- Generic name
- Stimulator, invasive bone growth
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 1994-11-15
- Decision date
- 1995-04-06
- Days to decision
- 142 days
- Decision code
- APPR
- Product code
- LOE
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.