SHARP(X)TM NEEDLE DESTRUCTION UNIT
FDA premarket approval P980015/S003 · decided 1999-09-17
Approval details
- PMA number
- P980015
- Supplement
- S003
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SHARP(X)TM NEEDLE DESTRUCTION UNIT
- Generic name
- Sharps needle destruction device
- Applicant
- Innovative Medical Systems, Inc.
- Date received
- 1999-09-14
- Decision date
- 1999-09-17
- Days to decision
- 3 days
- Decision code
- APPR
- Product code
- MTV
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Mountain Brook, AL
- Statement
- Approval for a modification of a contraindication statement in the labeling.
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 |
|---|---|---|
| VIOLA II DENTAL CAMERA SYSTEM (K973035) | Innovative Medical Systems, Inc. | 1997-09-24 |
| BAZOOKA SYSTEM (K951469) | Innovative Medical Systems, Inc. | 1995-06-28 |
| POSITIVE AIRWAY PRESSURE SYSTEM (K933184) | Innovative Medical Systems, Inc. | 1994-11-28 |
| MICROWAVE AUTOMATED TISSUE PROCESSOR (K924590) | Innovative Medical Systems, Inc. | 1992-12-29 |
| LABOTECH AUTOMATED MICROTITER ANALYZER (K922081) | Innovative Medical Systems, Inc. | 1992-09-02 |
| AUTOLOADER (K921005) | Innovative Medical Systems, Inc. | 1992-04-29 |
| PHACO 20/20 SYSTEM I (K915457) | Innovative Medical Systems, Inc. | 1992-02-24 |
| PHACO 3000 LINEAR (K915456) | Innovative Medical Systems, Inc. | 1992-02-12 |