INTEGRA DERMAL REGENERATION TEMPLATE, INTEGRA MESHED DERMAL REGENERATION TEMPLATE
FDA premarket approval P900033/S033 · decided 2014-04-07
Approval details
- PMA number
- P900033
- Supplement
- S033
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INTEGRA DERMAL REGENERATION TEMPLATE, INTEGRA MESHED DERMAL REGENERATION TEMPLATE
- Generic name
- Device, dermal replacement
- Applicant
- Integra Lifesciences Corp.
- Date received
- 2014-01-07
- Decision date
- 2014-04-07
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- MDD
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Plainsboro, NJ
- Statement
- APPROVAL FOR A DESIGN CHANGE TO THE INTEGRA® DERMAL REGENERATIONTEMPLATE. THE DESIGN CHANGE WAS TO PRODUCE A MESHED VERSION OF THE INTEGRA® DERMAL REGENERATION TEMPLATE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME INTEGRA® MESHED DERMAL REGENERATION TEMPLATE AND IS INDICATED FOR THE POST EXCISIONAL TREATMENT OF LIFE-THREATENING FULL-THICKNESS OR DEEP PARTIAL THERMAL INJURIES WHERE SUFFICIENT AUTOGRAFT IS NOT AVAILABLE AT THE TIME OF EXCISION OR NOT DESIRABLE DUE TO THE PHYSIOL
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 |
|---|---|---|
| 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 |