NORIAN SRS CEMENT
FDA premarket approval P970010/S002 · decided 2000-04-28
Approval details
- PMA number
- P970010
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Trade name
- NORIAN SRS CEMENT
- Generic name
- BONE CEMENT
- Applicant
- Synthes (Usa)
- Date received
- 2000-03-02
- Decision date
- 2000-04-28
- Days to decision
- 57 days
- Decision code
- APPR
- Product code
- LOD
- Advisory committee
- Physical Medicine
- Expedited review
- No
- Location
- Paoli, PA
- Statement
- Approval of the real time shelf life protocol for purposes of extending the shelf life.
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| SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS (K111667) | Synthes (Usa) | 2011-12-05 |