| Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device. |
| |
| Trade Name | ENDOTAK C LEAD, SQ PATCH LEAD, SQ LEAD ARRAY, DSP LEAD |
|---|
| Classification Name | implantable cardioverter defibrillator (non-crt) |
|---|
| Generic Name | nonthorocotomy leads for cardioverter |
|---|
| Applicant | GUIDANT CORP. |
|---|
| PMA Number | P910073 |
|---|
| Supplement Number | S022 |
|---|
| Date Received | 04/03/1997 |
|---|
| Decision Date | 09/19/1997 |
|---|
| Product Code | |
| Advisory Committee |
Anesthesiology |
|---|
| Supplement Type | normal 180 day track |
|---|
| Supplement Reason | change in location pilot |
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product |
No
|
|---|
Approval Order Statement
Appproval for a manufacturing site located at cardiac pacemakers, inc. , del caribe, road 698 lot no. 12, dorado, pr 00646. |
|
|
