R3 Biolox delta Ceramic Acetabular System
FDA premarket approval P150030/S008 · decided 2020-08-21
Approval details
- PMA number
- P150030
- Supplement
- S008
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- R3 Biolox delta Ceramic Acetabular System
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Smith & Nephew, Inc.
- Date received
- 2020-07-22
- Decision date
- 2020-08-21
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- Approval of a revised protocol for the post-approval study protocol.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.