|
Device | USCI(R)BALLOON DILATATION CATH. W/PETELITE(TM) |
Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
Regulation Number | 870.5100 |
Applicant | MEDTRONIC IRELAND Parkmore Business Park West Galway |
PMA Number | P790017 |
Supplement Number | S049 |
Date Received | 12/23/1992 |
Decision Date | 02/26/1996 |
Reclassified Date
|
10/08/2010 |
Product Code |
LOX |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MANUFACTURING CHANGES TO THE BALLOON AND INCLUDED THE USE OF A BALLOON PROTECTOR. THE DEVICES, AS MODIFIED, WILL BE MARKETED WITH THE PETELITE BALLOON DESIGNATION |