Brand Name | NCP PULSE GENERATOR |
Type of Device | PULSE GENERATOR |
Baseline Brand Name | NCP PULSE GENERATOR |
Baseline Generic Name | PULSE GENERATOR |
Baseline Catalogue Number | NA |
Baseline Model Number | 100 |
Baseline Device Family | NA |
Baseline Device 510(K) Number | |
Baseline Device PMA Number | P970003 |
Baseline Shelf Life Information |
Yes
|
Baseline Preamendment? |
No
|
Transitional? |
No
|
510(K) Exempt? |
No
|
Shelf Life(Months) | 18 |
Date First Marketed | 07/16/1997 |
Manufacturer (Section F) |
CYBERONICS, INC. |
100 cyberonics blvd. |
ste 600 |
houston TX 77058 |
|
Manufacturer (Section D) |
CYBERONICS, INC. |
100 cyberonics blvd. |
ste 600 |
houston TX 77058 |
|
Manufacturer Contact |
darlene
garner, rac
|
100 cyberonics blvd., ste. 600 |
houston
, TX 77058 |
(281)
228
-7200
|
|
Device Event Key | 502694 |
MDR Report Key | 513687 |
Event Key | 487387 |
Report Number | 1644487-2004-00164 |
Device Sequence Number | 1 |
Product Code | LYJ |
Report Source |
Manufacturer
|
Source Type |
Company Representative,Other
|
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
08/07/2002 |
1 Device Was Involved in the Event | |
1 Patient Was Involved in the Event | |
Date FDA Received | 03/02/2004 |
Is This An Adverse Event Report? |
Yes
|
Is This A Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device EXPIRATION Date | 06/30/2000 |
Device MODEL Number | 100 |
Device LOT Number | 19476C |
Was Device Available For Evaluation? |
No
|
Is The Reporter A Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 02/04/2004 |
Was Device Evaluated By Manufacturer? |
Device Not Returned To Manufacturer
|
Date Device Manufactured | 01/01/1999 |
Is The Device Single Use? |
Yes
|
Is this a Reprocessed and Reused Single-Use Device? |
No
|
Is the Device an Implant? |
Yes
|
Is this an Explanted Device? |
|
Type of Device Usage |
Initial
|
Patient TREATMENT DATA |
Date Received: 03/02/2004 Patient Sequence Number: 1 |
# | Treatment | Treatment Date |
1,MODEL 300-20 NCP BIPOLAR LEAD,, |
2,EXPIR DATE 9/30/2000, DATE OF MFG 9/23/1998,, |
3,STERILIZATION LOT NO. 16292C., |
|
|
|