Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenerat
FDA premarket approval P900033/S085 · decided 2019-08-28
Approval details
- PMA number
- P900033
- Supplement
- S085
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenerat
- Generic name
- Dressing, wound and burn, interactive
- Applicant
- Integra Lifesciences Corp.
- Date received
- 2019-07-31
- Decision date
- 2019-08-28
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MGR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Plainsboro, NJ
- Statement
- Implement a change of designation of meshed collagen product as master product and alignment of MIDRT bioburden specification with other members in the same sterilization product family
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 |