GARREN GASTRIC BUBBLE
FDA premarket approval P840025/S011 · decided 1987-03-17
Approval details
- PMA number
- P840025
- Supplement
- S011
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Other
- Trade name
- GARREN GASTRIC BUBBLE
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- American Edwards Laboratories
- Date received
- 1986-10-20
- Decision date
- 1987-03-17
- Days to decision
- 148 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Elkton, MD
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| EDSLAB (R) OCCLUSION BALLOON CATHETER (K873485) | American Edwards Laboratories | 1987-12-03 |
| TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30 (K872596) | American Edwards Laboratories | 1987-09-30 |
| THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2 (K872529) | American Edwards Laboratories | 1987-09-15 |
| HOMEPRO II VOLUMETRIC INFUSION PUMP (K870444) | American Edwards Laboratories | 1987-04-17 |
| MEDTRAC VP VOLUMETRIC INFUSION PUMP (K864997) | American Edwards Laboratories | 1987-02-27 |
| SHEAR FORCE GAUGE (K864330) | American Edwards Laboratories | 1987-01-06 |
| VEIN VALVE CUTTER (K862724) | American Edwards Laboratories | 1987-01-02 |
| MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS (K864155) | American Edwards Laboratories | 1986-11-20 |