Generator, Pulsatile Flow, Cardiopulmonary Bypass
JOR is the FDA product code for Generator, Pulsatile Flow, Cardiopulmonary Bypass, a class III device type, regulated under 21 CFR 870.4320. FDA's definition for this code reads: "Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before September 21, 2004, for any cardiopulmonary bypass pulsatile flow generator that was in commercial distribution before May 28, 1976, or that has, on or...". As of , FDA records hold no 510(k) clearances under this code and 2 recalls.
Classification record
- Product code
- JOR
- Device name
- Generator, Pulsatile Flow, Cardiopulmonary Bypass
- FDA definition
- Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before September 21, 2004, for any cardiopulmonary bypass pulsatile flow generator that was in commercial distribution before May 28, 1976, or that has, on or before September 21, 2004, been found to be substantially equivalent to any cardiopulmonary bypass pulsatile flow generator that was in commercial distribution before May 28, 1976. Any other cardiopulmonary bypass pulsatile flow generator shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
- Regulation
- 21 CFR 870.4320
- Device class
- Class III
- Review panel
- Cardiovascular
- Submission type
- PMA
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 0
- Ingested recalls
- 2
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code JOR.
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