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Chamber, Decompression, Abdominal

Page Type
Product Code
Regulation Medical Specialty
Obstetrical and Gynecological
Review Panel
Obstetrical and Gynecological
Submission Type
PMA
Device Classification
Class 3
Regulation Number
884.5225
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 884.5225 Abdominal decompression chamber

§ 884.5225 Abdominal decompression chamber.

(a) Identification. An abdominal decompression chamber is a hoodlike device used to reduce pressure on the pregnant patient's abdomen for the relief of abdominal pain during pregnancy or labor.

(b) Classification. Class III (premarket approval).

(c) Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any abdominal decompression chamber that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to an abdominal decompression chamber that was in commercial distribution before May 28, 1976. Any other abdominal decompression chamber shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

[45 FR 12684, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987; 61 FR 50709, Sept. 27, 1996]

Chamber, Decompression, Abdominal

Page Type
Product Code
Regulation Medical Specialty
Obstetrical and Gynecological
Review Panel
Obstetrical and Gynecological
Submission Type
PMA
Device Classification
Class 3
Regulation Number
884.5225
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 884.5225 Abdominal decompression chamber

§ 884.5225 Abdominal decompression chamber.

(a) Identification. An abdominal decompression chamber is a hoodlike device used to reduce pressure on the pregnant patient's abdomen for the relief of abdominal pain during pregnancy or labor.

(b) Classification. Class III (premarket approval).

(c) Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any abdominal decompression chamber that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to an abdominal decompression chamber that was in commercial distribution before May 28, 1976. Any other abdominal decompression chamber shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

[45 FR 12684, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987; 61 FR 50709, Sept. 27, 1996]