DIAPHRAGMATIC PACEMAKER PHRENIC NERVE
FDA premarket approval P860026/S006 · decided 2000-07-07
Approval details
- PMA number
- P860026
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- DIAPHRAGMATIC PACEMAKER PHRENIC NERVE
- Generic name
- implanted diaphragmatic/phrenic nerve Stimulator
- Applicant
- Avery Biomedical Devices, Inc.
- Date received
- 2000-04-27
- Decision date
- 2000-07-07
- Days to decision
- 71 days
- Decision code
- APPR
- Product code
- GZE
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Commack, NY
- Statement
- APPROVAL FOR PROCESS VALIDATION OF THE PROPOSED DEVICE STERILIZATION PROCEDURE, PROPOSED LABELING FOR THE DEVICE PACKAGING, AND THE PROPOSED CHANGES TO THE INSTRUCTION MANUAL. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MARK IV AND IS INDICATED FOR PERSONS WHO REQUIRE CHRONIC VENTILATORY SUPPORT BECAUSE OOF UPPER MOTOR NEURON RESPIRATORY MUSCLE PARALYSIS (RMP) OR BECAUSE OF CENTRAL ALVEOLAR HYPOVENTILATION (CAH) AND WHOSE REMAINING PHRENIC NERVE, LUNG, AND DIAPHRAGM FUNCTION
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