AMS COLLAGEN DERMAL MATRIX
FDA 510(k) clearance K050445 · decided 2005-06-17
Clearance details
- K-number
- K050445
- Device name
- AMS COLLAGEN DERMAL MATRIX
- Applicant
- American Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-02-22
- Decision date
- 2005-06-17
- Days to decision
- 115 days
- Clearance type
- Traditional
- Product code
- PAG
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Minnetonka, MN, US
- Third-party review
- No
- Expedited review
- No
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| MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX (K030460) | Brennen Medical, Inc. | 2003-03-07 |
| STRATASIS SLING KIT (K020654) | Cook Biotech, Inc. | 2002-04-09 |
| MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX (K993459) | Advanced Uroscience, Inc. | 1999-11-05 |
| SURGISIS SLING (K992159) | Cook Biotech, Inc. | 1999-09-23 |
| BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX (K982403) | Brennen Medical, Inc. | 1998-09-22 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AMS InteXen LP Collagen Dermal Matrix, REF 72404066. Product Size: 8 x 12 cm. AMS InteXen recall (Z-0932-2009) | American Medical Systems | 2009-01-27 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| 600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG SURGICAL LASERS (P940012/S002) | American Medical Systems, Inc. | 1998-12-23 |
| 600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG SURGICAL LASERS (P940012/S001) | American Medical Systems, Inc. | 1998-01-09 |
| 600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG SURGICAL LASERS (P940012) | American Medical Systems, Inc. | 1995-12-27 |