| 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 | MICRO-PACE DUAL-CHAMBER, DDD, TEMPORARY CARDIAC PACEMAKER |
|---|
| Classification Name | generator, pulse, pacemaker, external programmable |
|---|
| Generic Name | pacemaker |
|---|
| Regulation Number | 870.1750 |
|---|
| Applicant | PACE MEDICAL |
|---|
| PMA Number | P920032 |
|---|
| Supplement Number | S005 |
|---|
| Date Received | 06/25/1999 |
|---|
| Decision Date | 02/02/2000 |
|---|
| Product Code | |
| Advisory Committee |
Cardiovascular |
|---|
| Supplement Type | normal 180 day track |
|---|
| Supplement Reason | location change - other |
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product |
No
|
|---|
Approval Order Statement
Approval is for an alternate vendor located at princeton technology, inc. , 12 park avenue, hudson, new hampshire. |
|
|
