INTEGRA(R) DERMAL REGENERATION TEMPLATE,INTEGRA(R) MESHED DERMAL REGENERATION TEMPLATE,OMNIGRAFT (TM) DERMAL REGENERATIO
FDA premarket approval P900033/S042 · decided 2016-01-07
Approval details
- PMA number
- P900033
- Supplement
- S042
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- INTEGRA(R) DERMAL REGENERATION TEMPLATE,INTEGRA(R) MESHED DERMAL REGENERATION TEMPLATE,OMNIGRAFT (TM) DERMAL REGENERATIO
- Generic name
- Device, dermal replacement
- Applicant
- Integra Lifesciences Corp.
- Date received
- 2015-01-29
- Decision date
- 2016-01-07
- Days to decision
- 343 days
- Decision code
- APPR
- Product code
- MDD
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Plainsboro, NJ
- Statement
- APPROVAL FOR THE INTEGRA OMNIGRAFT DERMAL REGENERATION MATRIX (A.K.A. OMNIGRAFT) AND INTEGRA DERMAL REGENERATION TEMPLATE. INTEGRA OMNIGRAFT DERMAL REGENERATION MATRIX IS INDICATED FOR USE IN THE TREATMENT OF PARTIAL AND FULL-THICKNESS NEUROPATHIC DIABETIC FOOT ULCERS THAT ARE GREATER THAN SIX WEEKS IN DURATION, WITH NO CAPSULE, TENDON OR BONE EXPOSED, WHEN USED IN CONJUNCTION WITH STANDARD DIABETIC ULCER CARE AND INTEGRA DERMAL REGENERATION TEMPLATE IS INDICATED FOR THE POSTEXCISIONAL TREATMENT
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Codman Disposable Perforators (K183581) | Integra Lifesciences Corp. | 2019-01-20 |
| CereLink ICP Monitor, CereLink ICP Extension Cable (K183406) | Integra Lifesciences Corp. | 2019-01-11 |
| CodMan Certas Plus Programmable Valve (K182265) | Integra Lifesciences Corp. | 2018-11-20 |
| Codman Certas Plus Electronic Tool Kit (K181902) | Integra Lifesciences Corp. | 2018-10-25 |
| CUSA Excel+ (K150682) | Integra Lifesciences Corp. | 2015-12-18 |
| Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison Rongeurs, Integra (R) Miltex (R) Kerrison Rongeurs, Integra (R) Meisterhand (R) Kerrison Rongeurs (K150428) | Integra Lifesciences Corp. | 2015-04-16 |
| INTEGRA LICOX PTO2 MONITOR (K131184) | Integra Lifesciences Corp. | 2013-08-30 |
| JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS (K092227) | Integra Lifesciences Corp. | 2010-02-17 |