INTEGRA DERMAL REGENERATION TEMPLATE
FDA premarket approval P900033/S060 · decided 2017-03-01
Approval details
- PMA number
- P900033
- Supplement
- S060
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INTEGRA DERMAL REGENERATION TEMPLATE
- Generic name
- Dressing, wound and burn, interactive
- Applicant
- Integra Lifesciences Corp.
- Date received
- 2017-01-30
- Decision date
- 2017-03-01
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MGR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Plainsboro, NJ
- Statement
- Acknowledge Integras revisions to Integras LifeSciences Standard Operating Procedure (SOP) QTM-10-007 - Design Output Variable, and Manufacturing Control Quality Assurance Levels, to align with the recently updated ISO 14971:2012 Medical devices - Application of risk management to medical devices.
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 |