600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG SURGICAL LASERS
FDA premarket approval P940012/S002 · decided 1998-12-23
Approval details
- PMA number
- P940012
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- 600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG SURGICAL LASERS
- Applicant
- American Medical Systems, Inc.
- Date received
- 1998-03-24
- Decision date
- 1998-12-23
- Days to decision
- 274 days
- Decision code
- APPR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Minnetonka, MN
- Statement
- Approval for the additional indication for use for the reduction of obstruction and palliation of symptoms in patients with completely or partially obstrucint endobronchial nonsmall cell lung cancer (NSCLC).
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| RETROARC RETROPUBIC SLING SYSTEM (K132655) | American Medical Systems, Inc. | 2013-11-20 |
| AMS ELEVATE PC (K112842) | American Medical Systems, Inc. | 2011-10-25 |
| MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191 (K100807) | American Medical Systems, Inc. | 2010-06-07 |
| GREENLIGHT XPS LASER SYSTEM (K092735) | American Medical Systems, Inc. | 2009-11-09 |
| PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM (K090934) | American Medical Systems, Inc. | 2009-06-02 |
| AMS SPECTRA CONCEALABLE PENILE PROSTHESIS (K090663) | American Medical Systems, Inc. | 2009-04-09 |
| ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP (K090713) | American Medical Systems, Inc. | 2009-04-02 |
| AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE (K082677) | American Medical Systems, Inc. | 2008-12-23 |