AVITENE(R) MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH)
FDA premarket approval N17600/S015 · decided 1998-08-10
Approval details
- PMA number
- N17600
- Supplement
- S015
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AVITENE(R) MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH)
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Davol Inc., Sub. C. R. Bard, Inc.
- Date received
- 1998-07-21
- Decision date
- 1998-08-10
- Days to decision
- 20 days
- Decision code
- OK30
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Warwick, RI
- Statement
- Requested the elimination of the in-vivo hemostasis test, a heavy metals test done at an intermediate bulk stage of Avitene MCH Flur, and the routine performance of finished product sterility testing as part of the sterilization release criteria for each lot of product sterilized.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| VENTRALIGHT ST MESH (K101851) | Davol Inc., Sub. C. R. Bard, Inc. | 2010-07-15 |
| BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 0117080, 0117150, 0117160 (K092032) | Davol Inc., Sub. C. R. Bard, Inc. | 2009-12-08 |
| BARD 3DMAX MESH (K081010) | Davol Inc., Sub. C. R. Bard, Inc. | 2008-10-07 |
| BARD COMPOSITE L/P MESH (K061754) | Davol Inc., Sub. C. R. Bard, Inc. | 2006-10-23 |
| BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH (K061314) | Davol Inc., Sub. C. R. Bard, Inc. | 2006-06-02 |
| SALUTE II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 0113072, 0113073, 0113077, 0113079 (K051848) | Davol Inc., Sub. C. R. Bard, Inc. | 2005-08-11 |
| SALUTE FIXATION SYSTEM (K050610) | Davol Inc., Sub. C. R. Bard, Inc. | 2005-05-25 |
| AQUASENS FLUID MONITORING SYSTEM (K011069) | Davol Inc., Sub. C. R. Bard, Inc. | 2001-08-16 |