DARDIK BIOGRAFT FOR PERIPHERAL & AV ACCESS USE
FDA premarket approval P780002/S008 · decided 1990-09-11
Approval details
- PMA number
- P780002
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DARDIK BIOGRAFT FOR PERIPHERAL & AV ACCESS USE
- Generic name
- Tissue graft of 6mm and greater
- Applicant
- Synovis Surgical Innovations
- Date received
- 1990-01-24
- Decision date
- 1990-09-11
- Days to decision
- 230 days
- Decision code
- APPR
- Product code
- LXA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SYNOVIS COLLAGEN MATRIX (TBD) (K122306) | Synovis Surgical Innovations | 2013-03-08 |
| VERITAS COLLAGEN MATRIX (DRY) (K083039) | Synovis Surgical Innovations | 2008-11-26 |
| VERITAS COLLAGEN MATRIX (K062915) | Synovis Surgical Innovations | 2006-12-06 |
| VERITAS DRY COLLAGEN MATRIX, VERITAS DRY OR VERITAS PSD (K041669) | Synovis Surgical Innovations | 2004-10-27 |
| PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT (K040415) | Synovis Surgical Innovations | 2004-04-14 |
| PERI-STRIPS STAPLE LINE REINFORCEMENT-SLEEVE CONFIGURATION, PERI-STRIPS STAPLE LINE REINFORCEMENT-STRIP CONFIGURATION (K040119) | Synovis Surgical Innovations | 2004-03-17 |
| STEERABLE STYLET (K040001) | Synovis Surgical Innovations | 2004-03-09 |
| VERITAS COLLAGEN MATRIX (K030879) | Synovis Surgical Innovations | 2003-04-24 |