The following data is part of a premarket notification filed by Intermedics, Inc. with the FDA for 8mm Quantum Pulse/suprima Ii Pulse Generators.
Device ID | K911122 |
510k Number | K911122 |
Device Name: | 8MM QUANTUM PULSE/SUPRIMA II PULSE GENERATORS |
Classification | Implantable Pacemaker Pulse-generator |
Applicant | INTERMEDICS, INC. P.O. BOX 617 Freeport, TX 77541 -0617 |
Contact | Alaine Medio |
Correspondent | Alaine Medio INTERMEDICS, INC. P.O. BOX 617 Freeport, TX 77541 -0617 |
Product Code | DXY |
CFR Regulation Number | 870.3610 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-03-12 |
Decision Date | 1991-05-16 |