PURE-DENT (R)
FDA premarket approval P890070/S003 · decided 1995-01-27
Approval details
- PMA number
- P890070
- Supplement
- S003
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PURE-DENT (R)
- Generic name
- Powder, dusting, surgical
- Applicant
- Grain Processing Corp.
- Date received
- 1994-08-18
- Decision date
- 1995-01-27
- Days to decision
- 162 days
- Decision code
- APPR
- Product code
- KGP
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Muscatine, IA
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.